G7 AC E TABULAR SYSTEM Surgical Technique
One Surgeon. One Patient.
Over 1 million times per year, Biomet helps one surgeon provide personalized care to one patient. The science and art of medical care is to provide the right solution for each individual patient. This requires clinical mastery, a human connection between the surgeon and the patient, and the right tools for each situation. At Biomet, we strive to view our work through the eyes of one surgeon and one patient. We treat every solution we provide as if it’s meant for a family member. Our approach to innovation creates real solutions that assist each surgeon in the delivery of durable personalized care to each patient, whether that solution requires a minimally invasive surgical technique, advanced biomaterials or a patient-matched implant. When one surgeon connects with one patient to provide personalized care, the promise of medicine is fulfilled.
G7 Acetabular System
Table of Contents Quick Reference Guides.......................................................................................................................................................................................................2 Device Description................................................................................................................................................................................................................6 Preoperative Templating.....................................................................................................................................................................................................7 Patient Positioning................................................................................................................................................................................................................8 Acetabular Exposure.............................................................................................................................................................................................................8 Acetabular Reaming..............................................................................................................................................................................................................9 Optional Shell Trialing and Alignment........................................................................................................................................................................ 10 Positioning Guides Liner Trialing with Provisional Shell.............................................................................................................................................................................. 15 Trial Reduction and Range of Motion.......................................................................................................................................................................... 16 Acetabular Shell Insertion................................................................................................................................................................................................ 17 Supplemental Screw Fixation......................................................................................................................................................................................... 21 Optional Liner Trialing with Final Implant................................................................................................................................................................. 23 Optional Apical Plug.......................................................................................................................................................................................................... 24 Polyethylene Liner Insertion........................................................................................................................................................................................... 24 Modular Head Selection and Impaction.................................................................................................................................................................... 26 Final Reduction.................................................................................................................................................................................................................... 26 Polyethylene Liner Removal............................................................................................................................................................................................ 26 Primary Shell Removal...................................................................................................................................................................................................... 29 Straight Inserter Handle Assembly/Disassembly.................................................................................................................................................... 30 Curved Inserter Handle Assembly/Disassembly...................................................................................................................................................... 31 Implants.................................................................................................................................................................................................................................. 32 Instruments........................................................................................................................................................................................................................... 48 Indications............................................................................................................................................................................................................................. 71 Contraindications................................................................................................................................................................................................................ 71
Biomet as the manufacturer of the G7 System does not practice medicine. This surgical technique was developed in conjunction with healthcare professionals.
G7 Acetabular System Quick Reference Surgical Technique
Step 2: Reaming
Step 3: Instrument Selection
Step 4: Shell Trialing (optional)
Step 5: Shell Insertion
Step 6: Supplemental Screw Insertion (optional)
Step 7: Liner Trialing
Step 8: Liner Insertion
Step 9: Final Reduction
Step 1: Preoperative Planning OrthoSize.com
Note: There may be slight variations in colors between components.
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Quick Reference Implant Guide
SHELLS
PPS Limited Hole
Finned PPS Limited Hole
OsseoTi Limited and Multi Hole
LINERS
Neutral (E1 & ArComXL)
+5 Neutral (E1 & ArComXL)
Standard Freedom Constrained (E1 only)
High Wall (E1 & ArComXL)
10 Degree (E1 & ArComXL)
10 Degree Freedom Constrained (E1 only)
+5 Freedom Constrained (E1 only)
FEMORAL HEADS
CoCr Modular
Freedom CoCr
BIOLOX® delta
BIOLOX® delta Option
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G7 Acetabular System Quick Reference Polyethylene Guides
≈ Minimum Poly Liner Thickness at 45° (mm)
Shell Size 42 - A 44 - A
≈ Minimum Poly Liner Thickness at Apex (mm)
Head Size 28
32
36
40
Shell Size
44
42 - A
4.3
44 - A
28
32
36
40
44
4.7
46 - B
6.3
4.3
46 - B
6.7
4.7
48 - C
7.3
5.3
48 - C
7.7
5.7
50 - D
8.3
6.3
4.3
50 - D
8.7
6.7
4.7
52 - E
9.3
7.3
5.3
52 - E
9.7
7.7
5.7
10.3
8.3
6.3
4.3
10.7
8.7
6.7
4.7
11.3
9.3
7.3
5.3
11.7
9.7
7.7
5.7
11.3
9.3
7.3
11.7
9.7
7.7
5.7
11.7
9.7
7.7
14.7
12.7
10.7
54 - F 56 - F 58 - G 60 - G 62 - H 64 - H
54 - F 56 - F 58 - G 60 - G 62 - H
5.3
64 - H
66 - I
66 - I
68 - I
68 - I
70 - I*
11.3
9.3
7.3
70 - I*
72 - I*
72 - I*
74 - J*
74 - J*
76 - J* 78 - J*
14.3
12.3
76 - J*
10.3
78 - J*
80 - J*
80 - J*
* Available in OsseoTi Multi hole configuration only
45° Apex
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Head Size
Quick Reference Polyethylene Guides
Polyethylene Articulation Sizing
Shell 42 - A 44 - A 46 - B
10 Degree Face Changing Leg Length Chart
Head Size 28
32
36
40
44
42 mm
A - 28 B - 28
Cup Size
44 mm B - 32
46 mm
Line Size
Offset (mm)
Leg Length (mm)
Lateralization (mm)
A
3.2
2.4
2.1
B
3.6
2.7
2.3
48 - C
C - 28
C - 32
48 mm
C
3.7
2.8
2.4
50 - D
D - 28
D - 32
D - 36
50 mm
D
3.9
3
2.6
52 - E
E - 28
E - 32
E - 36
52 mm
E
4.1
3.1
2.7
F
4.3
3.2
2.8
G
4.4
3.4
2.9
H
4.8
3.6
3.1
I
5.1
3.9
3.3
J*
5.7
4.3
3.7
54 - F 56 - F 58 - G 60 - G 62 - H 64 - H
F - 28
F - 32
F - 36
F - 40
G - 28
G - 32
G - 36
G - 40
54 mm 56 mm 58 mm 60 mm 62 mm
H - 32
H - 36
H - 40
H - 44
66 mm
66 - I 68 - I 70 - I*
68 mm I - 36
I - 40
I - 44
72 mm 76 mm
74 - J*
78 - J*
70 mm 74 mm
72 - I*
76 - J*
64 mm
78 mm J - 36
J - 40
J - 44
80 mm
80 - J* *Available in OsseoTi Multi hole configuration only
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G7 Acetabular System Surgical Technique
Figure 1
G7 Acetabular System Color & Letter Coding Key
Color and Liner Size
Shell Size(s)
A
42,44 mm
B
46 mm
C
48 mm
D
50 mm
E
52 mm
F
54,56 mm
G
58,60 mm
H
62,64 mm
I
66, 68, 70*, 72* mm
J*
74, 76, 78, 80 mm
*Only available in multi hole shell configurations Figure 2
Device Description The hemispherical design of the G7 acetabular shell provides fixation and stability with proven PPS Porous Plasma Spray Coating or OsseoTi Porous Structure. Multiple bearing options are also available, including E1 Antioxidant Infused Technology and ArComXL Polyethylene. The G7 Acetabular System utilizes a unique color coding system designed to offer an efficient operating experience. The provisional shells, provisional liners, labels and face plate impactors match the color anodized on the rim and letter designation of the acetabular shell implant (Figure 1).
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The G7 Acetabular System color and letter coding key is listed in Figure 2. Note: Implant identification should be made using letter and size information. Color coding should be used only as a secondary reference. There may be slight variations in colors between components.
OrthoSize.com
Preoperative Templating Accurate preoperative planning and acetabular templating help determine the size, desired location and position of the acetabular shell and are an essential part of the surgical process. Templating is best performed with an A/P pelvis radiograph with the limb internally rotated approximately 15 degrees. This allows more accurate determination of femoral offset, radiographic leg length inequality, and referencing of contralateral hip, if required. When examining the A/P radiograph, the shell should be positioned against, but not medial to, the radiographic teardrop at 40 degrees of inclination. Acetabular shell size is best determined on a cross-table lateral radiograph. If the patient’s anatomy is obscured, it may be helpful to check the acetabular component size on the contralateral hip radiograph, as well.
Make note of the shell size that fills the acetabular space appropriately and fits the anterior to posterior diameter of the native acetabulum, keeping in mind that final decision on shell size should be made during surgery when adequate visualization of the acetabulum is achieved. Note: Use of an X-ray magnification marker is needed to template with OrthoSize Digital Templating Software. The magnification marker can be located against the joint (ball/ coin) or on the table (coin/ruler), but must be visible within the X-ray.
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G7 Acetabular System
Figure 3
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Patient Positioning
Acetabular Exposure
The G7 Acetabular System is designed to be used with all surgical approaches (Figure 3).
Prior to reaming, acetabular exposure should be adequate and the anterior, posterior and superior walls should be directly visible. The medial acetabular wall, which dictates the depth of the reaming, should be uncovered of floor osteophytes or pulvinar pad. Specialized acetabular retractors are available to help facilitate exposure for whichever approach is chosen.
Figure 4
Acetabular Reaming Determine a starting reamer size from the preoperative template and from the measured diameter of the resected femoral head. This is typically 6–8 mm smaller than the femoral head diameter. Reamer handles are provided as straight or curved (offset). Use is dictated by surgeon preference, surgical exposure, and patient body composition. During the reaming process, frequently determine the amount of anterior and posterior acetabular bone remaining to avoid reaming away the wall and compromising fixation. Beginning with a small reamer, apply constant pressure first toward the medial wall, appropriately medializing the acetabulum for optimal hip biomechanics and the normal center of hip rotation. Gradually progress to larger reamers, while maintaining concentricity within the acetabular cavity until bleeding subchondral bone is exposed (Figure 4).
The preferred acetabular orientation is 40 degrees inclination and 20 degrees of anteversion, but final acetabular position depends on patient anatomy and may vary slightly with approach. Final orientation of the acetabular implant is also dictated by the amount of version of the femoral implant (i.e., greater anteversion of the acetabular component may be required in the case of a retroverted stem). Under-reaming of the acetabulum is dependent on bone quality and should be determined by the surgeon intraoperatively as soft bone will more readily accommodate a larger press-fit than harder, sclerotic bone. The following reaming recommendation may be used as an initial guideline: Acetabular Shell
Recommended Under ream*
G7 PPS and OsseoTi Hemispherical Shell
1 mm under final implant size
G7 Finned Hemispherical Shell
Line to line
* This is a general recommendation only, appropriate reaming is dependent on bone quality and should be determined by the surgeon intraoperatively.
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G7 Acetabular System 180°
47 mm
180°
Figure 5 47 mm
180°
Figure 6
48 mm
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Acetabular Reaming (cont.)
Optional Shell Trialing and Alignment
Once reaming is complete, use the provisional shells to confirm the position and accuracy of the reaming. Final shaping must be achieved using the hemispherical grater reamer to ensure a congruent fit between the shell and the acetabulum.
Once the desired ream has been achieved, select a provisional shell that is 1 mm smaller than the final implant. The provisional shell is marked with its true size and indicates the corresponding liner size both alphabetically and by color (Figure 6).
Note: All G7 acetabular shells are measured over porous coating or structure. All acetabular shells, provisional shells and Biomet acetabular reamers are marked true to size. All components are a full hemisphere and measure 180 degrees (Figure 5).
The shell gauge handle may be threaded to the acetabular shell provisional and used to gauge the size of the reamed acetabulum (Figure 6). Note: Do not impact on the shell gauge handle.
Figure 7
Figure 8
Figure 9
Optional Shell Trialing and Alignment (cont.) Alternatively, utilize either the straight monoblock, curved or straight modular inserter handle. Place the provisional shell into the acetabulum at approximately 40 degrees of inclination and 20 degrees of anteversion.
When using the curved or straight modular handle, place the appropriate threaded shaft into the handle through the hole in the strike plate of the straight modular handle (Figures 7 and 8), or the hole at the distal tip of the curved inserter handle (Figure 9). If using the G7 Straight Monoblock Inserter Handle, assemble to the mating component by rotating clockwise and disassemble by rotating counter-clockwise. Ensure the G7 Monoblock Inserter Handle is fully threaded to the mating component prior to impaction. Note: Levering on the inserter handle or impacting the handle on a location other than the strike plate to reposition the shell may damage the threads.
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G7 Acetabular System
Figure 10
Figure 11
Figure 12
Optional Shell Trialing and Alignment (cont.) Insert the ball hex driver into the hole in the strike plate of the straight handle or the hole at the distal tip of the curved handle and turn to advance the threaded shaft until the threads are exposed (Figures 10 and 11).
Approximate version can be obtained by using the transverse acetabular ligament or by referencing the opening of the acetabular component 90 degrees off of the sciatic notch. Alternatively, a positioning guide may be used.
Line up the square tip of the insertion handle with the square at the apex of the shell trial. Turn the ball hex driver in a clockwise direction to advance the thread into the shell (Figures 10–12). Remove the ball hex driver from the handle. Ensure that the shell is securely fastened to the handle by lightly pulling on the provisional shell.
If using the G7 Straight Monoblock Inserter Handle, assemble to the mating component by rotating clockwise and disassemble by rotating counter-clockwise. Ensure the G7 Monoblock Inserter Handle is fully threaded to the mating component prior to impaction. Note: Levering on the inserter handle or impacting the handle on a location other than the strike plate to reposition the shell may damage the threads.
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Figure 13
Figure 14
Optional Shell Trialing and Alignment (cont.) Positioning Guides
Lateral Guide
The Lateral and Anterior Supine G7 positioning guides are designed to aid in proper insertion of the acetabular component.
When positioning the acetabular shell, the lateral guide arms should be parallel to the table, aimed toward the patient’s ipsilateral shoulder (Figure 13).
Assemble the positioning guide on the back table before securing to the insertion handle. Connect the body of the positioning guide to the insertion handle by sliding the guide into the opening between the handle grip and shaft on the inserter handle. Slide the positioning guide into the flat opening on the guide body. When the guide is in place, tighten the positioning guide rod to secure the guide to the handle (Figure 14).
For the right hip, use the reference arm of the “V” shaped guide labeled “RIGHT.” For the left hip, use the reference arm of the “V” shaped guide labeled “LEFT” (Figure 14).
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G7 Acetabular System
Figure 15
Optional Shell Trialing and Alignment (cont.) Supine Guide When positioning the acetabular shell, the anterior supine positioning guide arms should be parallel to the table, aligned with the patient’s spinal column (Figure 15). For the right hip, use the reference arm of the “V” shaped guide labeled “RIGHT.” For the left hip, use the reference arm of the “V” shaped guide labeled “LEFT” (Figure 15).
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Note: The primary reference for acetabular shell position should be based on the patient’s anatomy. These instruments rely significantly on patient position and are designed to be used only as a secondary verification. If at any time there is concern about acetabular position, the orientation may be verified with intraoperative fluoroscopy or with intraoperative radiographs. A true A/P pelvis without rotation is best indicated when the tip of the coccyx lines up with the pubic symphysis and is within 1–2 cm of the symphysis.
Figure 16
Optional Shell Trialing and Alignment (cont.) Optional Shell Trialing Lightly impact the provisional shell and confirm complete seating through the cutouts on the provisional shell (Figure 16). Remove any soft tissue or osteophytes from the acetabular rim that overhang the edge of the provisional component to obtain proper seating. If the provisional shell is unstable, or if there are gaps between the provisional shell and the acetabulum, it may be necessary to increase the diameter of the final reamer. However, in some instances it may not be possible to increase the reamed diameter. If this is the case, then supplementary screw fixation may be necessary. Disconnect the inserter handle from the provisional shell.
Figure 17
Liner Trialing with Provisional Shell Following seating of the provisional shell, select the appropriate provisional liner size, as indicated alphabetically and by color, in the desired liner configuration. Insert the provisional liner into the shell by hand. Utilize a 3.5 mm hex screwdriver to tighten the screw in the dome of the provisional liner into the apical hole of the provisional shell (Figure 17). Note: Do not overtighten the provisional liner.
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G7 Acetabular System
Figure 18
Figure 19
Trial Reduction and Range of Motion Select the appropriate provisional head, head diameter and neck length to create equal leg length and needed lateralization as determined by the surgeon. These determinations can be made during preoperative templating, but final adjustments are made intraoperatively. Insert the provisional head onto the implanted stem or broach and reduce the hip (Figures 18 and 19).
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Ensure the provisional head is seated fully on the trunnion. If using the G7 self retaining provisional head in combination with a Biomet Type 1 reduced taper, a click is felt and/or heard when the provisional head is fully seated. Check for joint stability and range of motion, making any necessary adjustments to restore joint mechanics. Make certain that prominent impinging bone and/or osteophytes are removed from the periphery of the acetabulum to maximize range of motion and stability. Make note of all provisional components used and then remove all provisionals.
Figure 20
Figure 21
Figure 22
Acetabular Shell Insertion Similar to provisional shell insertion, the same curved or straight handle may be used for the final implant shell insertion (Figure 20). Note: Limited hole shells are packaged with the screw holes pre-plugged. Should screw fixation be necessary, the screw hole covers should be removed using a 3.5 mm hex driver prior to shell insertion.
When using the curved or straight handle, place the appropriate threaded shaft (Figures 21 and 22) into the handle through the hole in the strike plate of the straight handle, or the hole at the distal tip of the curved handle inserter. If using the G7 Straight Monoblock Inserter Handle, assemble to the mating component by rotating clockwise and disassemble by rotating counter-clockwise. Ensure the G7 Monoblock Inserter Handle is fully threaded to the mating component prior to impaction.
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G7 Acetabular System
Figure 23
Figure 24
Acetabular Shell Insertion (cont.) Insert the ball hex driver into the hole in the strike plate of the straight handle or the hole at the distal tip of the curved handle and turn to advance the threaded shaft until the threads are exposed. Line up the square tip of the insertion handle with the square indentation on the inside of the G7 shell (Figure 23). Turn the ball hex driver in a clockwise direction to advance the thread into the shell (Figure 24). Note: If the threads begin to loosen when impacting the modular inserter handle, utilize the ball hex driver to retighten and continue impaction.
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Remove the ball hex driver from the handle. Note: When the curved handle is used, the curve of the insertion handle should line up with the screw holes on the shell. Ensure the shell is securely fastened to the handle by lightly pulling on the shell.
Figure 25
Figure 26
Acetabular Shell Insertion (cont.) Alternatively, each inserter handle may also be utilized to insert the shell with a face plate impactor. Select the appropriately sized impactor plate that matches alphabetically and by color to the implant. Thread the impactor plate onto the insertion handle with the word “insert” facing the user (Figure 25).
The face plate impactor will align with any of the anti-rotation tabs on the face of the shell for impaction. These plates may be used with or without the optional quick connect bolt, which threads onto the face plate impactor (Figure 26). This bolt then snaps into the apical hole of the implant to retain the shell on the face impactor. Once inserted, the face plate is disengaged from the shell by lightly pulling backwards.
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G7 Acetabular System
Figure 27
Acetabular Shell Insertion (cont.) Optional use of Positioning Guide The Lateral and Anterior Supine G7 positioning guides are designed to aid in proper insertion of the acetabular component. Utilizing the positioning guide as a reference, determine the correct position and alignment of the acetabular shell. See positioning guide section (Pages 13 and 14). In addition, approximate version can be obtained by using the transverse ligament or by referencing the opening of the acetabular component 90 degrees off of the sciatic notch. Position of the acetabular shell is crucial for optimizing wear, reducing impingement, reducing dislocation and reducing potential adverse outcomes. Use a mallet to impact the handle on the strike plate, driving the shell into the acetabulum. While impacting, note the position of the screw holes to obtain the optimal position for screw placement, typically in the posterior/ superior quadrant of the acetabulum (Figure 27). There are 2 indents on the shell rim, to provide a secondary reference in identifying screw hole locations after the implant is inserted.
Gently toggle the insertion handle to make certain the shell is stable. Once the implant is fully seated, reinsert the ball hex driver and turn in a counter-clockwise direction to release the threads from the shell. If using an impactor plate, pull back gently from the shell to disengage the plate. Check through the apical hole to determine whether the shell is in full contact with the floor of the acetabulum. If not, the impactor handle may be re-attached to the shell for further impaction, until the shell is fully seated. Failure to fully seat the shell into the acetabulum may compromise the quality of fixation. The force required to fully seat the implant depends on multiple factors including quality of bone, diameter of acetabulum and amount of underream. Ensure the G7 Straight Monoblock Inserter Handle is fully threaded to the mating component prior to impaction. Note: Levering on the inserter handle or impacting the handle on a location other than the strike plate to reposition the shell may damage the threads. Note: Consideration should be given to the location of screw holes prior to impaction if screws will be used.
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Limited hole configuration
Figure 28
Multi hole configuration
Figure 29
Supplemental Screw Fixation For primary cases where good bone stock is present and the shell is firmly seated within the acetabulum, the use of fixation screws is generally unnecessary. However, in cases where press-fit stability is in question, or where the bone quality is not optimal, supplementary screw fixation is advised. Screw placement must be chosen carefully to avoid injury to neurovascular structures. Optimal position for screw placement is typically in the posterior/superior quadrant of the acetabulum (Figure 28). Care should also be exercised when supplementary screw fixation is required to avoid damaging or scratching the internal surfaces of the acetabular components.
Use of the gold drill guide is required for accurate screw placement. Consideration should be given to placement of a screw near the dome of the implant first to prevent possible shifting of the implant caused when placing peripheral screws. Note: Placement of screws outside of the “safe zone” may inadvertently injure neurovascular structures and should be utilized at the discretion of the operating surgeon. When using G7 Limited Hole shells, screws should never be placed in the anterior/medial area of the acetabulum. When using the G7 OsseoTi Multi Hole shell, extreme caution should be used if screw placement is required in the anterior/medial area of the acetabulum.
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G7 Acetabular System
Figure 30
Figure 31
Figure 32
Supplemental Screw Fixation (cont.) Use the gold drill guide to drill a pilot hole in the desired screw hole (Figure 29). Make certain the drill guide is fully seated and locked into position within the screw hole BEFORE the drill bit begins to engage bone (Figure 30). This will ensure the appropriate screw direction can be achieved. The G7 screw holes allow approximately 15 degrees of variability. Screws oriented outside this range may result in incomplete seating of the screws and prominent screw heads within the shell, which could impede insertion of the liner. When drilling into the posterior/superior quadrant, place a finger posteriorly into the sciatic notch to ensure the screw cannot penetrate too deeply. Note: Levering on the drill bit during drilling may cause damage to the drill bit. Note: Use only gold colored screws and the gold colored drill guide with G7 implants. Note: Check that all screw heads are seated below the inner surface of the shell to ensure proper liner seating.
22
The drill bits are available in variable lengths. However, 30 or 40 mm drill bits are most commonly utilized. The drill bit chosen should be dictated by surgeon choice and the projected length of the screws. To ensure proper seating of the G7 acetabular screw after drilling pilot holes, it is important to remove all bone debris from the screw hole prior to placing the screw. After measuring the depth of the hole with the depth gauge (Figure 31), select the 6.5 mm gold colored screw with the corresponding length and insert it into the hole with the 3.5 mm hex screwdriver and screw forceps (Figure 32). Place additional screws as needed. Screws should not be placed in the apical hole of the shell.
Figure 33
Figure 34
Optional Liner Trialing with Final Implant Clean and dry the shell and clear all soft tissue from around its perimeter. If another trial reduction is desired, utilize the provisional liner colored to match the rim of the shell and previously selected during the earlier trial reduction with the matching letter designation. Insert the provisional liner into the shell by hand, utilizing a 3.5 mm hex screwdriver, tighten the screw in the dome of the provisional liner into the apical hole of the final implant (Figure 33). Note: Do not overtighten the provisional liner. Note: For ease of insertion, ensure the screw in the dome of the liner provisional is aligned with the apical hole of the final implant. Insert a provisional head onto the femoral stem and perform the trial reduction (Figure 34). When selection of the appropriate liner is complete, remove all provisional components. Note: G7 provisional heads are designed with a retaining feature. A click is felt and/or heard when the provisional head is fully seated.
When using a High Wall or 10 Degree Face Changing liner, note the position of the liner to maintain orientation during final seating or adjust rotation as necessary in order to minimize impingement and optimize stability.
Freedom Constrained Liner Trialing Determine the desired neck length and head size and select the appropriate trial head. Insert the provisional head onto the implanted stem or broach. Ensure the provisional head is seated fully on the trunnion and reduce the hip. Check for joint stability and range of motion, making any necessary adjustments to restore joint mechanics. Make certain that prominent impinging bone and/or ostephytes are removed from the periphery of the acetabulum to maximize range of motion and stability. Make note of all provisional components used and then remove all provisionals. Note: G7 Freedom provisional heads are uniquely shaped to allow for trialing with the definitive implant. These are the only heads compatible for trialing with G7 Freedom implant liners.
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G7 Acetabular System
Figure 36
˚
90
Figure 35
Figure 37
Optional Apical Plug
Polyethylene Liner Insertion
If desired, the apical hole in the acetabular shell can be covered with the plug packaged with the implant. Place the apical hole plug on the 3.5 mm hex screwdriver. Align the plug with the apical hole and twist the screwdriver clockwise to tighten the plug (Figure 35). Placing a drop of blood on the end of the screwdriver prior to attaching it to the apical hole plug may aid in retention of the plug on the screwdriver tip.
The definitive polyethylene liner may now be introduced. The color on the liner label should match the color anodized on the rim of the acetabular shell. Ensure the interior of the shell is dry and free of debris and overhanging soft tissue is removed. Manually place the liner into the shell, ensuring the scallops are correctly aligned with the recessed areas on the shell. Apply manual pressure to the dome region to provisionally secure the liner in place by lightly engaging the scallops. Utilizing the appropriately sized G7 ball impactor, place the tip of the impactor on the dome of the liner with the handle perpendicular to the face of the shell (Figure 36).
Note: Only G7 Limited Hole Shells are packaged with an apical plug.
Note: When inserting a 10 degree liner, the higher side of the liner should be placed superiorly and the insertion handle must be perpendicular with the face of the shell (Figure 37). Do not angle the handle to match the angled face of the liner. Strike the impactor with the mallet to begin impaction. Continue to impact with the handle perpendicular to the face of the shell until the liner is fully seated.
24
Note: If the liner becomes tilted during initial impaction, it is recommended that you do not impact the sides of the liner and instead manually remove and reseat the liner prior to additional impaction. Once in place, begin impaction again by delivering several firm mallet strikes with the tip of the impactor in the dome of the liner.
Correct Neutral Polyethylene Seating
Incorrect Neutral Polyethylene Seating Figure 38
Correct
Correct
Correct
Correct
+5 Neutral Liner Seating
Freedom Constrained Liner Seating
10 Degree Freedom Constrained Liner Seating
+5 Freedom Constrained Liner Seating
Freedom Plug Removal Cross Section Figure 39
Polyethylene Liner Insertion (Cont.)
Freedom Constrained Liner Insertion
Note: The impaction force needed to fully seat the liner into the acetabular shell may be dependent on liner size, liner style and polyethylene thickness. To ensure complete seating of the liner it may be necessary to utilize an impaction force similar to that which is needed to insert the acetabular shell.
Remove the black plug covering the mouth of the liner with the Freedom plug removal tool (Figure 39); discard this plug. Place the liner into the acetabular shell. When satisfied with placement, using the appropriately sized G7 Freedom ball impactor, place the tip of the impactor on the dome of the liner and strike the impactor with the mallet to ensure proper seating of the liner. When properly seated, there will be a slight gap between the constraining ring and the face of the shell. Pull on the liner by hand after insertion to ensure proper seating has been achieved.
Check to ensure the liner is fully seated by running your finger around the face of the shell. When properly seated, the polyethylene scallops will sit flush with, or slightly below, the face of the shell (Figure 38). Note: The ball impactor is slightly undersized to prevent excessive forces at the rim that may cause polyethylene deformation and prevent full seating.
Note: The diameter of the G7 36 mm size D Freedom liner ring is slightly larger than the G7 50 mm D shell. Care should be taken when using this construct. 25
G7 Acetabular System Freedom Etching
Figure 40
Figure 41
Modular Head Selection and Impaction With the definitive acetabular bearing in place, and upon completion of femoral implantation and trial reduction, the corresponding modular head can now be selected. After fully seating the femoral component, position the modular head onto a dry and clean trunnion. Fully seat the modular head by means of firm axial impaction utilizing the femoral head pusher and mallet. Note: If using a modular ceramic head with taper sleeve insert, it is important that the taper sleeve is new as a used taper can reduce fatigue strength of ceramic components. Note: When utilizing the Freedom liner, position the Freedom head on the stem so that the marking on the head is located in the most superior position prior to impaction.
Final Reduction Once all final implants have been placed, perform the final reduction of the hip. Check for joint stability and range of motion, making any necessary adjustments to restore joint mechanics (Figure 40).
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Note: When reducing a hip using the Freedom Constrained liner and head, ensure that the marking on the head is still in the superior position on the stem (Figure 41). Reduce the joint by aligning the flat aspect of the head with the liner’s mouth. Full reduction may produce an audible “snap.” Place the joint through a full range of motion to ensure stability, checking that there is no early impingement.
Figure 42
Polyethylene Liner Removal Should it be necessary to remove the liner from the shell, the polyethylene liner removal tool can be used to disassociate the liner. To remove the liner, insert the pointed tip of the liner removal tool between the liner and the shell with the tip positioned between the liner scallops. Start insertion with the grip angled toward the inner diameter of the shell. As the wedge is driven between the shell and the liner, gradually rotate the grip until vertical. Impact the polyethylene liner removal tool until the shoulder fully rests on the face of the shell (Figure 42). Apply a lever force to the liner by pressing against the shaft of the liner removal tool. It may be necessary to do this in several locations around the face of the shell to disengage the locking mechanism. The polyethylene liner will lever out of the shell once the locking mechanism has been disrupted. Note: Avoid driving the metal tip along the tapered region of the shell to prevent damage to the taper during liner extraction. Note: The polyethylene liner removal tool should only be used on a well fixed cup or a cup with acetabular screws.
10 Degree Liner
High Wall Liner
Figure 43
Figure 44
Polyethylene Liner Removal (cont.) Neutral Liner Removal Using Drill Instruments If using the Poly Liner Removal Drill Bit and Screw, first select the face plate corresponding to the letter and color of the shell size implanted. Turn the face plate upside down so that the word “extract” is facing you and attach it to an insertion handle. Align the tabs of the face plate to the recessed areas on the face of the shell. Insert the G7 Poly Liner Removal Drill Bit into either drill hole of the face plate (Figure 43). Drill a pilot hole for the poly removal screw and advance until the shoulder of the drill bit touches the face plate. Remove the face plate and handle. Using the ratcheting screwdriver handle, insert the Poly Liner Removal Screw into the pilot hole, advancing it all the way to the shell dome to remove the liner (Figures 44 and 45). Note: The Poly Liner Removal Drill Bit and Poly Liner
Removal Screw are delivered sterile for single use. Note: If the screw enters one of the shell screw holes,
remove the screw and repeat in an alternate location with a new drill bit and screw.
Figure 45
Figure 45a
10 Degree and High Wall Liner Removal with Drill Instruments Position the G7 Poly Liner Removal Drill Bit at the face of the polyethylene liner. Angle the drill bit at approximately 15 degrees from the axis of the shell and drill a pilot hole for the poly removal screw (Figure 45a). Should the drill cut through into the inner diameter of the polyethylene, drill a new hole in an alternate location around the rim, slightly decreasing the entrance angle relative to the axis of the shell. Drill the pilot hole until the shoulder of the drill bit touches the face of the liner or the drill tip touches the dome of the shell. Using the ratcheting screwdriver handle, insert the Poly Liner Removal Screw into the polyethylene and advance it all the way to the shell dome to remove the liner. Note: The Poly Liner Removal Drill Bit and Poly Liner
Removal Screw are delivered sterile for single use. Note: If the screw enters one of the shell screw holes, remove the screw and repeat in an alternate location with a new drill bit and screw.
27
G7 Acetabular System
15 Degrees
Figure 46
Figure 47
Figure 48
Polyethylene Liner Removal (cont.) Freedom Liner Removal Place the Poly Liner Removal Drill Bit at the interface of the liner and the constraining ring. Angle the drill bit at approximately 15° from the axis of the shell and drill a pilot hole for the poly removal screw (Figure 46).
Drill the pilot hole until the shoulder of the drill bit touches the face of the liner. Insert the Poly Liner Removal Screw into the poly and advance it all the way to the shell dome to remove the liner (Figure 47 and 48).
The drill should only enter the polyethylene, but remain close to the constraining ring.
Note: For sizes I & J, the poly removal drill bit may be inserted through the exposed polyethylene scallops or the polyethylene liner removal tool may be used in the same manner as with non-constraining liners.
Should the drill cut through into the inner diameter of the polyethylene, drill a new hole in an alternate location around the rim, slightly decreasing the entrance angle relative to the axis of the shell.
28
Note: When removing a Freedom 10 Degree liner, align the drill bit with the black line located on the raised portion of the liner and ensure the angle of the removal screw is nearly perpendicular to the face of the shell before drilling the pilot hole.
Figure 49
Figure 50
Primary Shell Removal To remove the acetabular shell, thread the extractor tool to a standard slap hammer and thread into the apical hole of the shell. Utilize the slap hammer to pull the shell directly out of the acetabulum, conserving as much bone as possible (Figure 49). Once the component is removed, careful evaluation of the acetabulum is suggested, with close attention to the integrity of the anterior/posterior columns and the medial wall. Any osteolytic cysts should be curetted and irrigated.
Note: In the unlikely event that the inserter handle threads may fracture during impaction and be left in the apical hole of the acetabular shell, utilize the Thread Extractor instrument for removal. The tapered tip of the Thread Extractor may be engaged in the small through hole of the fractured threads, allowing the fractured threads to be removed from the apical hole of the acetabular shell (Figure 50).
29
G7 Acetabular System Inserter Handle Assembly/Disassembly
Figure 51
Figure 52
Figure 53
Figure 54
Straight Inserter Handle Assembly/Disassembly Insertion handles are available in both curved and straight designs for ease of use, to limit modularity and to allow appropriate and thorough cleaning of instrumentation. Step 1: Obtain the straight inserter handle body and threaded shaft (Figure 51). Step 2: Insert the threaded shaft into the hole in the strike plate of the straight inserter handle body (Figure 52).
30
Step 3: Insert the ball hex driver into the hole in the strike plate of the straight inserter handle body. Turn clockwise to advance the threads of the internal shaft through the tip of the impaction handle (Figure 53). Step 4: To disassemble for cleaning, place a 3.5 mm hex screwdriver in the tip of the threaded shaft. Turn the screwdriver clockwise while pushing lightly to disengage the threaded shaft from the handle (Figure 54).
Figure 55
Figure 56
Figure 57
Figure 58
Curved Inserter Handle Assembly/Disassembly Step 1: Obtain the curved inserter handle body and the threaded insert (Figure 55). Step 2: Place the threaded insert into the tip of the handle body (Figure 56).
Step 3: Insert the ball hex driver into the hole in the tip of the curved handle as shown. The handle is designed to allow the user to angle the ball hex driver away from the inserter handle grip. Turn clockwise to advance the threads of the internal shaft through the tip of the impaction handle (Figure 57). Step 4: To disassemble for cleaning, place a 3.5 mm hex screwdriver in the tip of the threaded insert. Turn the screwdriver clockwise while pushing lightly to disengage the insert (Figure 58).
31
G7 Acetabular System Implants Product
Part Number
Diameter
Size/Offset
010000658
42 mm
A
010000659
44 mm
A
010000660
46 mm
B
010000661
48 mm
C
010000662
50 mm
D
010000663
52 mm
E
54 mm
F
56 mm
F
010000666
58 mm
G
010000667
60 mm
G
010000668
62 mm
H
010000669
64 mm
H
010000670
66 mm
I
010000671
68 mm
I
010000664 010000665
32
Description
PPS Limited Hole Acetabular Shell
Implants Product
Part Number
Diameter
Size/Offset
110017098
42 mm
A
110017099
44 mm
A
46 mm
B
48 mm
C
110017102
50 mm
D
110017103
52 mm
E
110017104
54 mm
F
110017105
56 mm
F
110017106
58 mm
G
60 mm
G
62 mm
H
110017109
64 mm
H
110017110
66 mm
I
110017111
68 mm
I
110017100 110017101
110017107 110017108
Description
PPS Finned Limited Hole Acetabular Shell 3 Hole*
PPS Finned Limited Hole Acetabular Shell 4 Hole*
*3 or 4 hole pattern dependent on shell diameter
33
G7 Acetabular System Implants Product
Part Number
Diameter
Size/Offset
110010239
42 mm
A
110010240
44 mm
A
46 mm
B
48 mm
C
110010243
50 mm
D
110010244
52 mm
E
110010245
54 mm
F
110010246
56 mm
F
110010247
58 mm
G
60 mm
G
62 mm
H
110010250
64 mm
H
110010251
66 mm
I
110010252
68 mm
I
110010259
42 mm
A
110010260
44 mm
A
110010261
46 mm
B
110010262
48 mm
C
110010263
50 mm
D
110010264
52 mm
E
110010265
54 mm
F
110010266
56 mm
F
110010267
58 mm
G
60 mm
G
62 mm
H
110010270
64 mm
H
110010271
66 mm
I
110010272
68 mm
I
110010273
70 mm
I
110010274
72 mm
I
110010275
74 mm
J
110010276
76 mm
J
110010277
78 mm
J
110010278
80 mm
J
110010241 110010242
110010248 110010249
110010268 110010269
*3 or 4 hole pattern dependent on shell diameter
34
Description
OsseoTi Limited Hole Acetabular Shell 3 Hole*
OsseoTi Limited Hole Acetabular Shell 4 Hole*
OsseoTi Multi Hole Acetabular Shell
Implants Product
Part Number
Description
Diameter
Size
010000718
A
010000719
B
010000720
C
010000721
28 mm
D
010000722
E
010000723
F
010000724
G
010000729
B
010000730
C
010000731
D
010000732
32 mm
010000733
E F
010000734
G
010000735
H
010000736
I
Neutral ArComXL Liner
010000739
D
010000740
E
010000741
F
010000742
36 mm
G
010000743
H
010000744
I
010000745
J
010000747
F
010000748
G
010000749
40 mm
H
010000750
I
010000751
J
010000753
H
010000754 010000755
44 mm
I J
35
G7 Acetabular System Implants Product
Part Number
Description
Diameter
010000835
A
010000836
B
010000837
C
010000838
28 mm
D
010000839
E
010000840
F
010000841
G
010000846
B
010000847
C
010000848
D
010000849
32 mm
E
010000850
F
010000851
G
010000852
H
010000856
Neutral E1 Liner
D
010000857
E
010000858
F
010000859
36 mm
G
010000860
H
010000861
I
010000862
J
010000864
F
010000865
G
010000866
40 mm
H
010000867
I
010000868
J
010000870 010000871 010000872
36
Size
H 44 mm
I J
Implants Product
Part Number
Description
Diameter
Size
110017165
A
110017166
B
110017167
C
110017168
28 mm
D
110017169
E
110017170
F
110017171
G
110017175
B
110017176
C
110017177
D
110017178
32 mm
110017179
E F
110017180
G
110017181
H
110017182
I
Neutral +5 mm ArComXL Liner
110017184
D
110017185
E
110017186
F
110017187
36 mm
G
110017188
H
110017189
I
110017190
J
110017191
F
110017192
G
110017193
40 mm
H
110017194
I
110017195
J
110017196
H
110017197 110017198
44 mm
I J
37
G7 Acetabular System Implants Product
Part Number
Description
Diameter
110017199
A
110017200
B
110017201
C
110017202
28 mm
D
110017203
E
110017204
F
110017205
G
110017209
B
110017210
C
110017211
D
110017212
32 mm
E
110017213
F
110017214
G
110017215
H
110017218
Neutral +5 mm E1 Liner
D
110017219
E
110017220
F
110017221
36 mm
G
110017222
H
110017223
I
110017224
J
110017225
F
110017226
G
110017227
40 mm
H
110017228
I
110017229
J
110017230 110017231 110017232
38
Size
H 44 mm
I J
Implants Product
Part Number
Description
Diameter
Size
010000796
A
010000797
B
010000798
C
010000799
28 mm
D
010000800
E
010000801
F
010000802
G
010000807
B
010000808
C
010000809
D
010000810
32 mm
E
010000811
F
010000812
G
010000813
H
010000814
I
High Wall ArComXL Liner
010000817
D
010000818
E
010000819
F
010000820
36 mm
G
010000821
H
010000822
I
010000823
J
010000825
F
010000826
G
010000827
40 mm
H
010000828
I
010000829
J
010000831
H
010000832 010000833
44 mm
I J
39
G7 Acetabular System Implants Product
Part Number
Description
Size
010000913
A
010000914
B
010000915
C
010000916
28 mm
D
010000917
E
010000918
F
010000919
G
010000924
B
010000925
C
010000926
D
010000927
32 mm
E
010000928
F
010000929
G
010000930
H
010000934
High Wall E1 Liner
D
010000935
E
010000936
F
010000937
36 mm
G
010000938
H
010000939
I
010000940
J
010000942
F
010000943
G
010000944
40 mm
H
010000945
I
010000946
J
010000948
H
010000949 010000950
40
Diameter
44 mm
I J
Implants Product
Part Number
Description
Diameter
Size
010000757
A
010000758
B
010000759
C
010000760
28 mm
D
010000761
E
010000762
F
010000763
G
010000768
B
010000769
C
010000770
D
010000771
32 mm
010000772
E F
010000773
G
010000774
H
010000775
I
10 Degree Face Changing ArComXL Liner
010000778
D
010000779
E
010000780
F
010000781
36 mm
G
010000782
H
010000783
I
010000784
J
010000786
F
010000787
G
010000788
40 mm
H
010000789
I
010000790
J
010000792
H
010000793 010000794
44 mm
I J
41
G7 Acetabular System Implants Product
Part Number
Description
Size
010000874
A
010000875
B
010000876
C
010000877
28 mm
D
010000878
E
010000879
F
010000880
G
010000885
B
010000886
C
010000887
D
010000888
32 mm
E
010000889
F
010000890
G
010000891
H
010000895
10 Degree Face Changing E1 Liner
D
010000896
E
010000897
F
010000898
36 mm
G
010000899
H
010000900
I
010000901
J
010000903
F
010000904
G
010000905
40 mm
H
010000906
I
010000907
J
010000909
H
010000910 010000911
42
Diameter
44 mm
I J
Implants Product
Part Number
Description
010000980
Diameter 32 mm
010000981 010000982
B C D
010000983 010000984
Size
E Freedom Constrained E1 Liner
010000985
F 36 mm
G
010000986
H
010000987
I
010000988
J
110010279
B
32 mm
110010280
C
110010281
D
110010282
E
110010283
10 Degree Freedom Constrained E1 Liner
110010284
F 36 mm
G
110010285
H
110010286
I
110010287
J
110010288
B
32 mm
110010289
C
110010290
D
110010291
E
110010292 110010293
+5 Freedom Constrained E1 Liner
F 36 mm
G
110010294
H
110010295
I
110010296
J
43
G7 Acetabular System Implants Product
Part Number
Description
010000994
Apical Hole Plug
010000995
Screw Hole Plug
010000996
6.5 mm x 15 mm
010000997
6.5 mm x 20 mm
010000998
6.5 mm x 25 mm
010000999
6.5 mm x 30 mm
010001000 010001001
44
Size x Length
G7 Low Profile Dome Screw
6.5 mm x 35 mm 6.5 mm x 40 mm
010001002
6.5 mm x 45 mm
010001003
6.5 mm x 50 mm
010001004
6.5 mm x 60 mm
010001005
6.5 mm x 70 mm
Implants Product
Part Number
Description
Diameter
Size/Offset
163666
+12 mm*
163665
+9 mm*
163638
+6 mm
163663
28 mm
+3 mm
163662
Std (0 mm)
163661
-3 mm
163660
-6 mm
163673
+12 mm*
163672
+9 mm*
163674
+6 mm
163670
32 mm
+3 mm
163669
Std (0 mm)
163668
-3 mm
163667
-6 mm
11-363666
+12 mm*
11-363665
+9 mm
11-363664 11-363663
+6 mm Type 1 CoCr Femoral Head
36 mm
+3 mm
11-363662
Std (0 mm)
11-363661
-3 mm
11-363660
-6 mm
010001031
+12 mm*
010001032
+9 mm
010001033
+6 mm
010001034
40 mm
+3 mm
010001035
Std (0 mm)
010001036
-3 mm
010001037
-6 mm
010001038
+12 mm
010001039
+9 mm
010001040
+6 mm
010001041
44 mm
+3 mm
010001042
Std (0 mm)
010001043
-3 mm
010001044
-6 mm
* Skirted
45
G7 Acetabular System Implants Product
Part Number
Description
Diameter
110025127
+6 mm
110025126
32 mm
110025128 110025129 14-107021 14-107020
+3 mm Std (0 mm) -3 mm +9 mm
Type 12/14 Freedom CoCr Modular Head
14-107019
+6 mm 36 mm
14-107018
+3 mm Std (0 mm)
14-107017
-3 mm
14-107016
-6 mm
110025134
+6 mm
110025130
+3 mm
110025131
32 mm
Std (0 mm)
110025132
-3 mm
110025133
-6 mm
11-107021
Type 1 Freedom CoCr Modular Head
+9 mm
11-107020 11-107019 11-107018
46
Size/Offset
+6 mm 36 mm
+3 mm Std (0 mm)
11-107017
-3 mm
11-107016
-6 mm
Implants Product
Part Number
Description
Diameter
650-1055
28 mm
650-1056
32 mm
650-1057
BIOLOX® delta Option Head
36 mm
650-1058
40 mm
650-1059
44 mm* +6 mm
650-1068 650-1067 650-1066 650-1065
Size/Offset
+3 mm
Type 1 Taper Sleeve for BIOLOX® delta Option
0 mm -3 mm
650-1064
-6 mm
650-1063
+7 mm
650-1062 650-1061
+4 mm
Type 12/14 Taper Sleeve for BIOLOX® delta Option
0 mm
650-1060
-3 mm +3 mm
650-1157 650-1158
28 mm
0 mm
650-1159
-3 mm
650-1160
+6 mm
650-1161 650-1162 650-1163
Type 1 BIOLOX® delta Ceramic Modular Heads
32 mm
650-0661 650-0660
0 mm -3 mm
650-0663 650-0662
+3 mm
+6 mm 36 mm
+3 mm 0 mm -3 mm
47
G7 Acetabular System G7 instrument cases will be shipped with all instruments included under one kit number, unless noted as optional.
C A
B D
F
E H
G
I
L K
P
M
J N
O
Q
110026842 G7 Efficient Wave Tray (Instruments Included) Product
Label
Part Number
Description
Quantity
A
110003457
Ratcheting Screwdriver Handle
1
B
110010717
Depth Gauge
1
C
010002736
Ball Hex Driver for Inserter Handles
1
D
110010733
Flexible Drill Shaft
1
E
424417
Screw Forceps
1
H
110010721
Dual Angle Drill Guide
1
I
110018823
Positioning Guide Post
1
K
010002748
U-Joint Modular Screwdriver 3.5 mm
1
K
010002749
Straight Modular Screwdriver 3.5 mm
1
M
010002723
Face Plate Quick Connect
2
010002724
Ball Impactor for 28 mm ID Liners
1
010002725
Ball Impactor for 32 mm ID Liners
1
010002726
Ball Impactor for 36 mm ID Liners
1
P
31-478350
Thread Extractor
1
Q
110018822
Positioning Guide Rod
1
110025612
G7 Efficient Wave Tray (Empty)
1
110027267
G7 Efficient Wave Tray Replacement Lid
1
O
48
Optional G7 Efficient Wave Tray Instruments Product
Label
Part Number
Description
Quantity
F
110003456
Lateral Positioning Guide
1
F
110003455
Anterior Supine Positioning Guide
1
G
110003453
Curved Acetabular Shell Inserter
1
L
110003450
Straight Monoblock Acetabular Shell Inserter
2
L
110003451
Straight Modular Inserter Handle (must be ordered with 110003452)
2
J
110003452
Straight Inserter Handle Threaded Shaft (must be ordered with 110003451)
1
N
110003454
Curved Inserter Threaded Shaft
2
49
G7 Acetabular System
B A
E
C
D
F
I G
J
H
K
L M
110005146 G7 Impaction Instrument Kit (Instruments Included) Product
Label
Part Number
Description
Quantity
A
110003456
Lateral Positioning Guide
1
B
110003451
Straight Modular Inserter Handle (must be ordered with 110003452)
1
C
110018823
Positioning Guide Post
1
D
010002745
Bent Shell Gauge / Suction Cup Handle
1
E
110003330
Monoblock Hex Screwdriver 3.5 mm
1
G
110018822
Positioning Guide Rod
1
010002724
Ball Impactor for 28 mm ID Liners
1
010002725
Ball Impactor for 32 mm ID Liners
1
010002726
Ball Impactor for 36 mm ID Liners
1
010002727
Ball Impactor for 40 mm ID Liners
1
010002728
Ball Impactor for 44 mm ID Liners
1
I
010002736
Ball Hex Driver for Inserter Handles
1
J
110003454
Curved Inserter Threaded Shaft
2
K
010002723
Face Plate Quick Connect
2
L
110003453
Curved Acetabular Shell Inserter
1
H
50
110005146 G7 Impaction Instrument Kit (Instruments Included cont.) Product
Label M
Part Number
Description
Quantity
110003452
Straight Inserter Handle Threaded Shaft (must be ordered with 110003451)
1
110027265
G7 Impaction Instrument Tray (Empty)
1
110027267
G7 Wave Tray Replacement Lid
1
Optional G7 Impaction Instruments Product
Label
Part Number
Description
Quantity
B
110003450
Straight Monoblock Acetabular Shell Inserter
1
F
110003455
Anterior Supine Positioning Guide
1
110010571
Sterile Suction Cup (Single use)
1
110010732
G7 Tamp
51
G7 Acetabular System
A
B
C
E D
F
G I
H K
J
110010207 G7 Screw Instrument Kit (Instruments Included) Product
Label
Part Number
Description
A
010002750
Screwdriver Sleeve
B
31-478350
Thread Extractor
C
110003457
Ratcheting Screwdriver Handle
D
110010717
Depth Gauge
E
110003501
Polyethylene Liner Removal Tool
F
110010733
Flexible Drill Shaft
G
110010721
Dual Angle Drill Guide
H
424417
Screw Forceps
I
010002749
Straight Modular Screwdriver 3.5 mm
J
010002748
U-Joint Modular Screwdriver 3.5 mm
K
31-302003
3/8 Shell Extractor
110027266
G7 Screw Instrument Tray (Empty)
110027267
G7 Wave Tray Replacement Lid
Optional G7 Screw Instruments Product
52
Label
Part Number
Description
010002746
Poly Liner Removal Drill Bit (Single use)
010002751
Poly Liner Removal Screw (Single use)
Note: The following items were sterile validated in the Miscellaneous Bin on the Screw Instrument Tray: Head Provisionals, Liner Provisionals, Liner Provisional Screws
H
G F E D C
110010224 Patient-Specific Mini Tray Provisional Kit (Instruments Included) Label
Part Number/Color
Description
C
Blue
Size C
D
Green
Size D
E
Purple
Patient-Specific Mini Tray
Diameter/Size
Size E
F
Yellow
G
Grey
Size G
Size F
H
Blue
Size H
110002769
Double Layer Outer Case and Lid
110002770
Patient-Specific Mini Tray Rack (empty)
Detail of contents included on following pages.
53
G7 Acetabular System
A B
C
D
110010212 Micro Size A/B Patient-Specific Mini Tray Product
Label
Part Number
Description
010002611 A
010002612
28 mm A Provisional Neutral Liner
010002621
C
D
28 mm B 32 mm B
010002713 B
Diameter/Size
Size A Face Plate Impactor
010002714
Size B
010002442
41 mm A
010002444
Provisional Shell
43 mm A
010002446
45 mm B
010002645
28 mm A
010002646
Provisional High Wall Liner
010002655 110004130
28 mm B 32 mm B
G7 Size A/B Provisional Caddy (Empty)
Micro Size A/B Patient-Specific Mini Tray - Optional Instruments Product
Part Number
Description
010002679 010002680 010002689
54
Diameter/Size 28 mm A
Provisional 10 Degree Liner
28 mm B 32 mm B
A
B
C
D
Size C Patient-Specific Mini Tray Product
Label
Part Number
Description
010002613 A
28 mm C Provisional Neutral Liner
010002622 B
010002448
32 mm C Provisional Shell
010002647 C
47 mm C 28 mm C
Provisional High Wall Liner 010002656
D
Diameter/Size
010002715 110002763
32 mm C Face Plate Impactor
Size C
G7 Size C Patient-Specific Mini Tray (Empty)
Size C Patient-Specific Mini Tray - Optional Instruments Product
Part Number 010002681 010002690
Description Provisional 10 Degree Liner
Diameter/Size 28 mm C 32 mm C
55
G7 Acetabular System
A
B
C
D
Size D Patient-Specific Mini Tray Product
Label
Part Number
Description
010002623 A
32 mm D Provisional Neutral Liner
010002630 B
010002450
36 mm D Provisional Shell
010002657 C
49 mm D 32 mm D
Provisional High Wall Liner 010002664
D
Diameter/Size
010002716 110002764
36 mm D Face Plate Impactor
Size D
G7 Size D Patient-Specific Mini Tray (Empty)
Size D Patient-Specific Mini Tray - Optional Instruments Product
Part Number
Description
Diameter/Size
010002614
Provisional Neutral Liner
28 mm D
010002648
Provisional High Wall Liner
28 mm D
010002682 010002691 010002698
56
28 mm D Provisional 10 Degree Liner
32 mm D 36 mm D
A
B
C
D
Size E Patient-Specific Mini Tray Product
Label
Part Number
Description
010002624 A
32 mm E Provisional Neutral Liner
010002631 B
010002452
36 mm E Provisional Shell
010002658 C
51 mm E 32 mm E
Provisional High Wall Liner 010002665
D
Diameter/Size
010002717 110002765
36 mm E Face Plate Impactor
Size E
G7 Size E Patient-Specific Mini Tray (Empty)
Size E Patient-Specific Mini Tray - Optional Instruments Product
Part Number
Description
Diameter/Size
010002615
Provisional Neutral Liner
28 mm E
010002649
Provisional High Wall Liner
28 mm E
010002683 010002692 010002699
28 mm E Provisional 10 Degree Liner
32 mm E 36 mm E
57
G7 Acetabular System
A
C B
D
Size F Patient-Specific Mini Tray Product
Label
Part Number
Description
010002625 A
32 mm F Provisional Neutral Liner
010002632 B
Diameter/Size
010002718
36 mm F Face Plate Impactor
010002454 C
Size F 53 mm F
Provisional Shell 010002456
55 mm F
010002659 D
32 mm F Provisional High Wall Liner
010002666 110002766
36 mm F G7 Size F Provisional Patient-Specific Mini Tray (Empty)
Size F Patient-Specific Mini Tray - Optional Instruments Product
Part Number
Description
Diameter/Size
010002616
Provisional Neutral Liner
28 mm F
010002650
Provisional High Wall Liner
28 mm F
010002684 010002693 010002700
58
28 mm F Provisional 10 Degree Liner
32 mm F 36 mm F
A
C B
D
Size G Patient-Specific Mini Tray Product
Label
Part Number
Description
010002626 A
32 mm G Provisional Neutral Liner
010002633 B
Diameter/Size
010002719
36 mm G Face Plate Impactor
010002458 C
Size G 57 mm G
Provisional Shell 010002460
59 mm G
010002660 D
32 mm G Provisional High Wall Liner
010002667
36 mm G
110002767
G7 Size G Patient-Specific Mini Tray (Empty)
Size G Patient-Specific Mini Tray - Optional Instruments Product
Part Number
Description
Diameter/Size
010002617
Provisional Neutral Liner
28 mm G
010002651
Provisional High Wall Liner
28 mm G
010002685 010002694 010002701
28 mm G Provisional 10 Degree Liner
32 mm G 36 mm G
59
G7 Acetabular System
A
B
C D
Size H Patient-Specific Mini Tray Product
Label
Part Number
Description
010002627 A
32 mm H Provisional Neutral Liner
010002634
36 mm H
010002462 B
61 mm H Provisional Shell
010002464 C
Diameter/Size
010002720
63 mm H Face Plate Impactor
010002661 D
Size H 32 mm H
Provisional High Wall Liner 010002668
36 mm H
110004131
G7 Size H Patient-Specific Mini Tray (Empty)
Size H Patient-Specific Mini Tray - Optional Instruments Product
Part Number 010002695 010002702
60
Description Provisional 10 Degree Liner
Diameter/Size 32 mm H 36 mm H
B
A
D C
Macro Size I Patient-Specific Mini Tray Product
Label A
B
Part Number 010002628
Description Provisional Neutral Liner
D
32 mm I
010002635
36 mm I
010002466
65 mm I
010002468 010002470
Provisional Shell
010002472 C
Diameter/Size
010002662 010002669 010002721 110004132
67 mm I 69 mm I 71 mm I
Provisional High Wall Liner
Face Plate Impactor
32 mm I 36 mm I Size I
G7 Size I Patient-Specific Mini Tray (Empty)
Macro Size I Patient-Specific Mini Tray - Optional Instruments Product
Part Number 010002696 010002703
Description Provisional 10 Degree Liner
Diameter/Size 32 mm I 36 mm I
61
G7 Acetabular System
A
B
D C
Macro Size J Patient Specific Mini Tray Product
Label
Part Number
Description
010002629 A
B
32 mm J Provisional Neutral Liner
010002636
36 mm J
010002474
73 mm J
010002476 010002478
Provisional Shell
010002480
75 mm J 77 mm J 79 mm J
010002663 C
32 mm J Provisional High Wall Liner
010002670 D
Diameter/Size
010002722 110010230
36 mm J Face Plate Impactor
Size J
G7 Size J Patient Specific Mini Tray (Empty)
Macro Size J Patient Specific Mini Tray Optional Instruments Product
Part Number
Description
010002697 010002704 010002709
32 mm J Provisional 10 Degree Face Changing Liner
010002712 110003622
62
Diameter/Size 36 mm J 40 mm J 44 mm J
Provisional Ceramic Liner
48 mm J
28 mm
32 mm
36 mm
40 mm (optional)
-6 mm offset
-3 mm offset
0 mm offset
110010211 28/32/36 mm Head Provisional Type 1 Half Tray Kit (Instruments Included) Part Number
Description
110002768
Head Provisional Type 1 Half Tray (Empty)
Offset
010002486
+9 mm
010002487
+6 mm
010002488 010002489
28 mm Type 1 Provisional Head
+3 mm Std (0 mm)
+3 mm offset
+6 mm offset
+9 mm offset
Optional Instruments Part Number
Description
Offset
010002485
28 mm Type 1 Provisional Head
+12 mm
010002492
32 mm Type 1 Provisional Head
+12 mm
010002499
36 mm Type 1 Provisional Head
+12 mm
010002490
-3 mm
010002506
+12 mm
010002491
-6 mm
010002507
+9 mm
010002493
+9 mm
010002508
+6 mm
010002509
+3 mm
010002510
Std (0 mm)
010002511
-3 mm
010002497
-3 mm
010002512
-6 mm
010002498
-6 mm
010002513
+12 mm
010002500
+9 mm
010002514
+9 mm
010002501
+6 mm
010002515
+3 mm
010002516
Std (0 mm)
010002517
010002504
-3 mm
010002518
-3 mm
010002505
-6 mm
010002519
-6 mm
010002494 010002495 010002496
010002502 010002503
32 mm Type 1 Provisional Head
36 mm Type 1 Provisional Head
40 mm Type 1 Provisional Head
44 mm Type 1 Provisional Head
+6 mm +3 mm Std (0 mm)
+6 mm +3 mm Std (0 mm)
63
G7 Acetabular System
A
C
D B
11018289 G7 Freedom Provisional Mini Tray 32 and 36 mm Product
Label
Part Number
Description
32 mm B
010002602 010002603
32 mm C
010002604
36 mm D
010002605 A
Diameter/Size
010002606 010002607
G7 Provisional Freedom Constrained Liner
36 mm E 36 mm F 36 mm G
010002608
36 mm H
010002609
36 mm I
010002610
36 mm J
110010729
+6 mm
110010727
+3 mm
110010724
32 mm
110010725 110010728 B
31-127021 31-127020 31-127019 31-127018
64
Offset
STD (0 mm) -3 mm -6 mm
Freedom Provisional Head Type 1
+9 mm +6 mm 36 mm
+3 mm STD (0 mm)
31-127017
-3 mm
31-127016
-6 mm
110018289 G7 Freedom Provisional Mini Tray 32 and 36 mm (cont.) Product
Label
Part Number
Description
C
31-107039
Freedom Plug Removal Tool
110017403 D
Diameter/Size
32 mm Freedom Liner Impactor
110017402
36 mm
110018290
G7 Freedom Provisional Mini Tray (Empty)
Part Number
Description
Optional Instruments Product
Label
Diameter/Size
110010722
+6 mm
110010731
32 mm
110010726 110010723 -
31-137021 31-137020 31-137019 31-137018
Offset +3 mm STD (0 mm) -3 mm +9 mm
Type 12/14 Freedom Provisional Head
+6 mm 36 mm
+3 mm STD (0 mm)
31-137017
-3 mm
31-137016
-6 mm
65
G7 Acetabular System 110010943 G7 Neutral/High Wall Provisional Liner Pack F-J 40 mm Description
Diameter/Size 40 mm F 40 mm G
Provisional Neutral Liner
40 mm H 40 mm I 40 mm J 40 mm F 40 mm G
Provisional High Wall
40 mm H 40 mm I 40 mm J
110010945 G7 Neutral/High Wall Provisional Liner Pack H-J 44 mm Description
Diameter/Size 44 mm H
Provisional Neutral Liner
44 mm I 44 mm J 44 mm H
Provisional High Wall
44 mm I 44 mm J
66
110010941 G7 10 Degree Micro Provisional Liner Pack A-B 28/32 mm Description
Diameter/Size 28 mm A
Provisional 10 Degree Liner
28 mm B 32 mm B
110010940 G7 10 Degree Provisional Liner Pack C-H 28/32/36 mm Description
Diameter/Size 28 mm C 28 mm D 28 mm E 28 mm F 28 mm G 32 mm C 32 mm D
Provisional 10 Degree Liner
32 mm E 32 mm F 32 mm G 32 mm H 36 mm D 36 mm E 36 mm F 36 mm G 36 mm H
110010942 G7 10 Degree Macro Provisional Liner Pack I 32/36 mm Description Provisional 10 Degree Liner
Diameter/Size 32 mm I 36 mm I
110010944 G7 10 Degree Provisional Liner Pack F-J 40 mm Description
Diameter/Size 40 mm F 40 mm G
Provisional 10 Degree Liner
40 mm H 40 mm I 40 mm J
110010948 G7 10 Degree Provisional Liner Pack H-J 44 mm Description
Diameter/Size 44 mm H
Provisional 10 Degree Liner
44 mm I 44 mm J
67
G7 Acetabular System 110018302 G7 10 Degree Freedom Constrained Provisional Liner Pack B-J 32/36 mm Description
Diameter/Size 32 mm B 32 mm C 36 mm D 36 mm E
Provisional Freedom 10 Degree Liner
36 mm F 36 mm G 36 mm H 36 mm I 36 mm J
Freedom Liner Impactor
32 mm 36 mm
Freedom Plug Removal Tool
110018301 G7 +5 mm Freedom Constrained Provisional Liner Pack B-J 32/36 mm Description
Diameter/Size 32 mm B 32 mm C 36 mm D 36 mm E
Provisional Freedom +5 mm Liner
36 mm F 36 mm G 36 mm H 36 mm I 36 mm J
Freedom Liner Impactor Freedom Plug Removal Tool
68
32 mm 36 mm
110018298 G7 Neutral +5 mm Provisional Liner Pack A-J 28-44 mm Description
Diameter/Size 28 mm A 28 mm B 28 mm C 28 mm D 28 mm E 28 mm F 28 mm G 32 mm B 32 mm C 32 mm D 32 mm E 32 mm F 32 mm G 32 mm H
Provisional Neutral +5 mm Liner
36 mm D 36 mm E 36 mm F 36 mm G 36 mm H 36 mm I 36 mm J 40 mm F 40 mm G 40 mm H 40 mm I 40 mm J 44 mm H 44 mm I 44 mm J
69
G7 Acetabular System 110010237 G7 Provisional Apical Locking Screw (10 pack) Description Provisional Apical Locking Screw (10 pack)
Single Use Drill Bits Part Number
Description
Size
31-323215
3.2 mm x 15 mm
31-323220
3.2 mm x 20 mm
31-323230
3.2 mm x 30 mm
31-323240 31-323250
3.2 mm x 40 mm
Drill Bit
3.2 mm x 50 mm
31-323260
3.2 mm x 60 mm
31-323270
3.2 mm x 70 mm
31-323280
3.2 mm x 80 mm
Outer Cases Part Number
Description
110002769
Double Layer Outer Case and Lid
110010236
Single Layer Outer Case and Lid
JN444
Aesculap Container
JK489
Aesculap Lid
110010238
Outer Case Replacement Lid
G7 X Ray Templates
70
Part Number
Description
XR010000658-1
G7 PPS & Finned Xray Template 100%
XR010000658-2
G7 PPS & Finned Xray Template 110%
XR010000658-3
G7 PPS & Finned Xray Template 115%
XRAY000162
G7 PPS & Finned Xray Template 120%
XR110010239-1
G7 OsseoTi Xray Template 100%
XR110010239-2
G7 OsseoTi Xray Template 110%
XR110010239-3
G7 OsseoTi Xray Template 115%
XR110010239-4
G7 OsseoTi Xray Template 120%
INDICATIONS 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use. Indications for Biomet G7 Freedom Constrained Liners: The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained Acetabular components have been considered.
CONTRAINDICATIONS Absolute contraindications include: infection, sepsis, and osteomyelitis. Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders who are incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. Contraindications when shell is used with Biomet G7 Freedom Constrained Liner: Bone or musculature compromised by disease, infection, or prior implantation that cannot p rovide adequate support or fixation for the prosthesis. For full prescribing information, including Indications for Use, Contraindications, Warnings, Precautions and Possible Adverse Effects, see the package insert and “Patient Risk Information” tab on biomet.com.
71
Notes
All content herein is protected by copyright, trademarks and other intellectual property rights owned or licensed to Biomet Inc. or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Biomet. This material is intended for health care professionals and the Biomet sales force. Distribution to any other recipient is prohibited. For complete product information, including indications, contraindications, warnings, precautions, and potential adverse effects, see the package insert and www.Biomet.com. BIOLOX® delta is a trademark of CeramTec AG. This technique was prepared in conjunction with licensed health care professionals. Biomet does not practice medicine. The treating surgeon is responsible for determining the appropriate treatment, technique(s), and product(s) for each individual patient.
Legal Manufacturer Biomet Orthopedics P.O. Box 587 56 E. Bell Drive Warsaw, Indiana 46581-0587 USA Biomet UK Ltd. Waterton Industrial Estate Bridgend, South Wales CF31 3XA UK Note: For Ceramic components contained within this Surgical Technique Biomet UK, Ltd is the Legal Manufacturer. ©2015 Biomet Orthopedics • Form No. BMET0120.5 • REV0615
www.biomet.com
