PROCOTYL L. Acetabular Cup System

Transcription

1 PROCOTYL L Acetabular Cup System S U R G I C A L T E C H N I Q U E

2

3 Contents Chapter 2 3 Chapter 2 4 Chapter Appendix A Appendix B 9 Design Rationale Design Features of the PROCOTYL L Cup Pre-operative Planning Surgical Technique PROCOTYL L Cup Preparation of the Acetabulum PROCOTYL L Reaming Guide Inserting the Shell Screw Placement and Fixation Trial Liner Placement Dome Plug Insertion Liner Placement X-linked Poly Liner Removal Ceramic / Metal Liner Removal Technique Overview Ordering Information PROCOTYL L Cups RIM-LOCK Ceramic Liners RIM-LOCK Metal Liner RIM-LOCK X-linked Poly Liner BIOLOX Delta Heads CoCr Super Finish Heads Screws Instrumentation PROCOTYL L Acetabular Cup System Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects.

4 Design Rationale chapter The PROCOTYL L Acetabular Cup System provides unsurpassed surgical flexibility for shell fixation and bearing material choices. The shells are manufactured from titanium alloy, the material of choice for bio-compatibility. An irregularly layered porous titanium bead coating enhances initial fixation and long term bone apposition. An average porosity of 30% allows for enhanced bone on-growth. Cups are available with or without additional hydroxyapatite coating. Three screw holes located in one quadrant of the cup allow for surgical flexibility. Intra-operative flexibility: PROCOTYL L Acetabular Cup System system accepts ceramic, metal and and A-Class advanced cross-linked poly liners. Liners are securely locked by the Rim-Lock fixation system and the 8 internal taper. PROCOTYL L acetabular components are recommended to be used in conjunction with PROFEMUR femoral components and their unique modular neck system. Modular necks allow for optimal restoration of patient s original hip biomechanics. Independent of the femoral shaft position, it allows control over leg length, offset, alignment and version. The 3 in-line screw holes are positioned away from the dome of the cup to achieve a maximum lever arm, optimal purchase in the illiac wing and thereby maximizing stability. The screws have a 200 freedom of direction. X-ray courtesy of Dr. E. Tozzi, Pisa- Calambrone, Italy Today s orthopedic surgeons face many challenges with acetabular fixation. As improved mechanical designs, bearing materials and techniques diminish short term failures, the focus has moved to long term survivorship. The PROCOTYL L Acetabular Cup System has integrated several design features to address contemporary issues. The intrinsic design features that address contemporary two-piece acetabular cup issues, coupled with multiple liner configurations, make the PROCOTYL L Acetabular Cup System the choice for surgeons requiring a wide range of primary, revision and bearing material options. The unique internal taper and Rim-Lock locking groove allows polyethylene, metal, or ceramic bearing liners to be used in a single shell design. A 4 rim flare geometry transfers load to the periphery of the acetabulum, providing long term intrinsic stability. Cups come with three holes for additional fixation by means of screws. From size 44 and up these holes are provided with a plug, including the apical hole. 2 PROCOTYL L Acetabular Cup System

5 Design Features of the PROCOTYL L Cup Ordering Information Templates LNG2CL0E 00 Lip Liner Surgical Technique Instruments Implants LNG2CL02E 50 Lip Liner EH E APH04400 PLPCKITA non coated cups PLHAKITA HA-coated cups CERAKITB ceramic liners XLINKITB poly liners METAKITB metal liners SUFIKITA metal heads CERAKITA ceramic heads Secure initial stability Additional screw fixation Proven on-growth surface Sintered Titanium beads 30% Porosity - avg. 4 µm pore size Increase ball bearing diameters 46mm cup - 32mm head 52mm cup - 36mm head Proven outer geometry Hemi-spherical - Single radius 52 Flattened dome Equatorial rim flare (40) Comes in sizes (2 mm increments) A-Class Advanced X-linked Poly liner 00 and 50 lip options 3600 lip position 28, 32 and 36mm inside diameters PROCOTYL L cup accommodates 3 types of liners Ceramic liner Alumina Matrix composite 00 lip Standard offset Taper locking 28, 32 and 36mm inside diameters Metal liner Cobalt Chrome 00 lip Standard offset Taper locking 28, 32 and 36mm inside diameters PROCOTYL L Acetabular Cup System 3

6 Pre-operative Planning chapter 2 Pre-operative Planning Pre-operative assessment of the appropriate size and position of the acetabular component will provide intra-operative guidance for acetabular reaming. A bilateral A/P x-ray of the pelvis will aid in leg length and offset assessment and management. Leg length discrepancies should be determined pre-operatively and addressed intra-operatively. Radiographic overlays for the PROCOTYL L Acetabular Cup System are available in 5% magnification, with 0 or 5 liners. To determine the acetabular cup size and position, place the overlay outline at approximately 45 of abduction and the center of rotation within the anatomic center of the acetabular image. Note: The use of a magnification marker will aid in determining the x-ray magnification. Caution: Pre-operative templating is intended for estimation purposes only. Final component size and position should be determined intra-operatively. 4 Chapter 2 Pre-operative Planning

7 Surgical Technique chapter 3 Preparation of the Acetabulum Osteophytes should be removed to enable assessment of the true acetabular rim. Reaming should be sequential and start with the smallest reamer that conforms to the acetabular cavity. Reaming to the edge of the reamer will mimic a full hemisphere. Gradually enlarge the acetabulum by reaming articular cartilage until a continuous surface of cancellous bone is exposed. Note: PROCOTYL L shells come in 2mm increments, ranging from mm. Ream to the size of the component to be implanted. This will provide a 2mm press fit at the rim, and a mm press fit at the dome. Reaming depth, acetabular shape and size can be confirmed by using a trial shell sizer. Chapter 3 Surgical Technique 5

8 PROCOTYL L Cup Reaming Guide For equatorial press-fit of mm ream to 2mm ream to PROCOTYL L size 42 43mm 42mm PROCOTYL L size 44 45mm 44mm PROCOTYL L size 46 47mm 46mm PROCOTYL L size 48 49mm 48mm PROCOTYL L size 50 5mm 50mm PROCOTYL L size 52 53mm 52mm PROCOTYL L size 54 55mm 54mm PROCOTYL L size 56 57mm 56mm PROCOTYL L size 58 59mm 58mm PROCOTYL L size 60 6mm 60mm PROCOTYL L size 62 63mm 62mm PROCOTYL L size 64 65mm 64mm PROCOTYL L size 66 67mm 66mm PROCOTYL L size 68 69mm 68mm A trial shell adapter (APA0930) is put onto the tip of the cup inserter instrument before mounting the trial shell which corresponds with the final reamer. The adapter is kept in place by a locking ring; the shell is fixed by turning the central rod of the cup inserter clock-wise. Following trialing the shell and adapter are to be removed from the cup inserter instrument. Use of the PROCOTYL L trial acetabular components is strongly suggested in order to verify depth of reaming as the initial stability of the acetabular component is predominatly provided by its rim flare. Reaming therefore needs to be performed sufficiently deep in order to fully seat the cup within the bony cavity. Note: The trial shells are equal in dimensions to the corresponding final implant but without rim flare and porous coating. Note: In cases where hard (sclerotic) bone is encountered and/or most of the subchondral plate is kept intact, the user may experience some difficulty inserting the trial shell. This may indicate a very tight fit with the shell and it is recommended that the cavity is reamed up by mm. In cases where there is no hard bone and the trial cup can easily be inserted but nevertheless initial final implant stability can not be obtained, it may be of help to ream the acetabular cavity slightly deeper with the last used reamer. 6 Chapter 3 Surgical Technique

9 Inserting the Shell A full series of cup size dedicated adapters (APA APA09309) is available in the instrument kit. The adapter corresponding to the preferred cup size is put onto the tip of the cup impactor, followed by the acetabular component. The pins on both arms of the adapter are to match the dimples in the face of the cup. This method of stabilization provides full control over the position of the cup at impaction. Note: The face of the shell has three laser marked lines that correspond to the screw hole locations. Position the marks between the plane of the anterior-superior and the anterior-inferior iliac spine. Seat the shell with a series of firm mallet blows on the end of the impactor. Once seated, the cup inserter instrument can be removed by turning the central rod counter-clockwise. Complete seating of the implant can be confirmed through the apical hole. Chapter 3 Surgical Technique 7

10 Inserting the Shell (continued) Screw placement can begin once the shell component is securely positioned and the impactor is removed. In case re-positioning of the cup is required, the cup inserter instrument can be mounted again and the cup can be removed, re-oriented and re-implanted. If a deeper seating is preferred, it might help to attach the cup impactor tip to the universal rod and use this as a cup inserter device. The flat of the cup impactor tip is to be positioned properly against the flat of the cup dome before hitting the universal handle with a hammer. Two alignment rods (APA09302) can be mounted on the inserter to aid in positioning the implant at 45 of abduction and 5 of ante-version. Position the longitudinal guide rod 90 to the midline of the patient to position the shell at 45. Position the transverse guide rod parallel to the midline of the patient as this will place the implant at 5 of inclination. Positions given are based on a posterior approach / affected side up. Note: The patient might have shifted during surgery and the alignment rods can therefore only be seen as an orientation guide. 8 Chapter 3 Surgical Technique

11 Screw Placement and Fixation PROCOTYL L shells are designed to allow additional fixation by means of screws; the shells come pre-plugged except for size 42 mm shell. Determine screw location and select a suitable length drill bit. Drill bits are provided in 3.2 and 4.5mm diameters; the drill guide is also available in 3.2 and 4.5mm diameters. Insert the drill into the guide and carefully drill through the acetabular cortex. Use the screw depth gauge to determine the appropriate screw length. Caution: Due to intra-pelvic vascular structures, screw placement in the medial aspect of the acetabulum must be carefully considered. Chapter 3 Surgical Technique 9

12 Grasp the screw head with the screw holding forceps and utilize the hex screwdiver to orient and fixate the screw. Centralize the screw to protect the threads from abrasion and assures countersinking of the screw head within the hole. Release the screw holding forceps to allow for countersinking of the screw head, which allows full seating of the prosthetic liner. Full seating of the liner can be confirmed with the use of a trial liner prior to impacting the prosthetic liner, or by manually examining the inner surface of the shell to check if the screw head is proud. Caution: To ensure proper prosthetic liner seating in the shell, all screw heads must be seated below the inner surface of the shell. Full and unobstructed seating is crucial to implant fit and longevity. Trial Liner Placement Trial liners that match the prosthetic implant are available to evaluate the optimum position of the implant and the preferred liner. With the prosthetic shell secured within the reamed cavity, insert the trial liner into the shell. 0 Chapter 3 Surgical Technique

13 Note: Care should be taken to avoid neck / liner impingement in all potential positions. The acetabular component should be repositioned as necessary to relieve impingement. Alternatively, a change of modular neck could possibly solve the impingement phenomenon. Position the trial liner in the desired orientation and secure it with the captured screw using a 3.5mm hex screwdriver. If a lipped liner is to be used, a reference mark should be made on the acetabulum to aid in proper positioning of the final liner implant. Note: The hard-on-hard liners allow for larger bearing diameters than polyethylene liners, which causes an overlap in the femoral head size range. The difference between group C 28/32 and group E 32/36 is made clear by trial liner colour coding. Chapter 3 Surgical Technique

14 Dome Plug Insertion After a satisfactory trial reduction and assessment of joint stability, seal the dome hole with the special plug. Whereas the screw hole plugs are pre-mounted, the dome hole plug comes separate in the packaging (except size 42 mm). The plug can be attached to the tip of the straight hex driver shaft and will be kept in place by the retaining mechanism. Note: The dome hole plug should not be inserted until a trial reduction with the trial liner is completed. Liner Placement Assemble a 0 or 5 lipped liner positioner to the impactor handle. Place the liner and hold it by hand. Place the liner in the selected position making sure the face of the liner is parallel to the face of the shell. Apply a series of firm mallet blows to fully seat the liner, followed by removal of the inserter. 2 Chapter 3 Surgical Technique

15 Caution: Improper position and impaction of the liner will damage the liner. Hard-on-hard bearing liners are inserted by hand. The inserter handle with mounted liner positioner is applied and fixation is achieved by some light taps. Note: Make sure that the rim of the liner is circumferentially flush with the face of the shell before final seating. Chapter 3 Surgical Technique 3

16 X-linked Poly Liner Removal To remove a poly liner, a flexible drill bit with an acetabular drill guide is used to drill a hole slightly off center from the liner apex. Using a 3.5mm hex screwdriver, a cancellous screw (20mm) is then advanced into the drilled hole until the liner is removed. Ceramic / Metal Liner Removal To remove a ceramic or metal liner a liner extractor is used. Position the tip of the liner extractor in a dimple in the face of the cup and apply some short mallet strokes. This results in a counteraction loosening the liner; repetitive action might be necessary. 4 Chapter 3 Surgical Technique

17 Technique Overview. Preparation of the Acetabulum - reaming. Preparation of the Acetabulum - trial shell to check reamed cavity 3. Inserting the Shell 4. Screw Placement - drilling 5. Screw Placement - fixation 6. Trial Liner Evaluation 7.Trial Liner Insertion 8. Dome Plug Insertion 9. Liner Placement Liner Options: XLPE 00 and 50 Ceramic Metal Chapter 3 Surgical Technique 5

18 Ordering Information Appendix A PROCOTYL L Cups PLPCKITA Catalog# Cup Size Inner Ø Group Equatorial Diameter Sph. R Height PHA * 35 A PHA B PHA C PHA C PHA D PHA E PHA E PHA F PHA F PHA G PHA G PHA G PHA G PHA G * Does not possess screw / dome hole plugs PROCOTYL L HA Coated Cups PLHAKITA With HA Coating Cup Size Inner Ø Group Equatorial Diameter Sph. R Height PHA * 35 A PHA B PHA C PHA C PHA D PHA E PHA E PHA F PHA F PHA G PHA G PHA G PHA G PHA G * Does not possess screw / dome hole plugs 6 Appendix A Ordering Information

19 RIM-LOCK Ceramic Liners CERAKITB Catalog # Group Head Diam. Cup Size PHA04502 A PHA04504 B 44 PHA04506 C PHA04508 D 50 PHA0450 E PHA0452 F PHA0454 G RIM-LOCK Metal Liners METAKITB Catalog # Group Head Diam. Cup Size PHA04702 A PHA04704 B 44 PHA04706 C PHA04708 D 50 PHA0470 E PHA0472 F PHA0474 G RIM-LOCK X-linked Poly Liners XLINKITB 50 Lip 00 Lip Group Head Diam. Cup Size PE at the dome in mm PE at 450 in mm PHA04654 PHA04604 B PHA04656 PHA04606 C PHA04658 PHA04608 D PHA04660 PHA0460 E PHA04662 PHA0462 F PHA04664 PHA0464 G Appendix A Ordering Information 7

20 BIOLOX Delta Head CERAKITA Catalog # Size PHA mm PHA mm PHA mm PHA mm PHA mm PHA mm PHA mm PHA mm PHA mm CoCr Super Finish Head SUFIKITA Catalog # Size mm mm mm mm mm mm mm mm mm mm mm mm Titanium Cancellous Screws 6.5mm Ø / 3.5mm hex Catalog # Length Catalog # Length mm mm mm mm mm mm mm mm 8 Appendix A Ordering Information

21 Instrumentation APH04400 Appendix B Cup Impactor Orientation Rod Trial Cup Impactor Adapter Cup Impactor Adapter Group A - B - C - D - E - F - G Trial Acetabular Cup Sizes RIM-LOCK Trial Liners 50 Lip RIM-LOCK Trial Liners 00 Lip Poly Liner Positioners Ø Poly Lipped Liner Positioners Ø Ceramic and Metal Liner positioners Ø Final Cup Impactor Tip Ceramic / Metal Liner Extractor Tommy Bar Universal handle for liners positioner Appendix B Instrumentation 9

22 Screw holder Drill bits Hex driver shaft straight solid 3.5mm Universal joint 3.5mm hex driver shaft Flexible drill / screw shaft Flexible screw depth gauge Ratchet screwdriver handle with quick connection Fixed angle drill guide 3.2mm / 4.5mm 20 Appendix B Instrumentation

23 PROCOTYL L Instruments APH04400 Note: Reamers are not included in the PROCOTYL L instruments set. Catalog # Description Quantity LNG2CL0E X-ray templates 5% magnification 00 lip liner LNG2CL02E X-ray templates 5% magnification50 lip liner FNA00470 Sterilization container (empty) FNA00473 Lid for tray APA0930 Cup impactor APA09302 Orientation rod 2 APA0930 Trial cup impactor adapter APA09303 APA09304 APA09305 APA09306 APA09307 APA09308 APA09309 APA09322 APA09324 APA09326 APA09328 APA09330 APA09332 APA09334 APA09336 APA09338 APA09340 APA09342 APA09344 APA09346 APA09348 Cup impactor adapter group A Cup impactor adapter group B Cup impactor adapter group C Cup impactor adapter group D Cup impactor adapter group E Cup impactor adapter group F Cup impactor adapter group G Trial acetabular cup size 42 Trial acetabular cup size 44 Trial acetabular cup size 46 Trial acetabular cup size 48 Trial acetabular cup size 50 Trial acetabular cup size 52 Trial acetabular cup size 54 Trial acetabular cup size 56 Trial acetabular cup size 58 Trial acetabular cup size 60 Trial acetabular cup size 62 Trial acetabular cup size 64 Trial acetabular cup size 66 Trial acetabular cup size 68 FNA0047 Sterilization container 2 (empty) FNA00474 Lid for tray 2 PPB3902 Tommy bar PPR68030 PPR68038 APA04565 APA0933 Universal handle for: Poly standard / lipped liner positioner Ceramic / metal liner positioner Ceramic / metal liner positioner ø 28 Ceramic / metal liner positioner ø 32 Ceramic / metal liner positioner ø 36 Appendix B Instrumentation 2

24 Catalog # Description Quantity APA07054 APA07056 APA093 Poly liner positioner ø 28 Poly liner positioner ø 32 Poly liner positioner ø 36 APA07060 APA07062 APA0932 Poly lipped liner positioner ø 28 Poly lipped liner positioner ø 32 Poly lipped liner positioner ø 36 APA09382 APA09384 APA09386 APA09388 APA09390 APA09392 APA09394 APA09396 APA09398 RIM-LOCK Trial liner 00 lip 28 Group A RIM-LOCK Trial liner 00 lip 28 Group B RIM-LOCK Trial liner 00 lip 28 Group C RIM-LOCK Trial liner 00 lip 32 Group C RIM-LOCK Trial liner 00 lip 32 Group D RIM-LOCK Trial liner 00 lip 32 Group E RIM-LOCK Trial liner 00 lip 36 Group E RIM-LOCK Trial liner 00 lip 36 Group F RIM-LOCK Trial liner 00 lip 36 Group G APA09364 APA09366 APA09368 APA09370 APA09372 APA09374 RIM-LOCK Trial liner 50 lip 28 Group B RIM-LOCK Trial liner 50 lip 28 Group C RIM-LOCK Trial liner 50 lip 32 Group D RIM-LOCK Trial liner 50 lip 32 Group E RIM-LOCK Trial liner 50 lip 36 Group F RIM-LOCK Trial liner 50 lip 36 Group G APA0934 Ceramic / Metal liner extractor PPR68070 Final cup impactor tip FNA00472 Sterilization container 3 (empty) FNA00475 Lid for tray SH0000 Screw holder 8400DG0 Fixed angle drill guide 3.2mm / 4.5mm 8400FD0 Flexible drill / screw shaft 8400FD FD FD FD QCRH Drill bit 3.2 x 25mm Drill bit 3.2 x 35mm Drill bit 4.5 x 25mm Drill bit 4.5 x 35mm Ratchet screwdriver handle with quick connection 8400SD03 Universal joint 3.5mm hex driver shaft 8400SD06 Hex driver shaft straight solid 3.5mm 8400SG0 Flexible screw depth gauge 22 Appendix B Instrumentation

25 Notes 23

26 24 Notes

27

28 Wright Medical Technology, Inc Airline Road Arlington, TN phone toll-free Wright Medical EMEA Krijgsman 86 DM Amstelveen The Netherlands phone Trademarks and Registered marks of Wright Medical Technology, Inc. Patents pending. 200 Wright Medical Technology, Inc. All Rights Reserved. EH E Rev 04

29 PROCOTYL O Acetabular Cup System S U R G I C A L T E C H N I Q U E PROFEMUR Total Hip System

30 PROFEMUR Total Hip System

31 Contents Chapter 2 3 Chapter 2 4 Chapter Appendix A Appendix B 9 Design Rationale Design Features of the PROCOTYL O Cup Pre-operative Planning Surgical Technique PROCOTYL O Cup Preparation of the Acetabulum PROCOTYL O Reaming Guide Inserting the Shell Screw Placement and Fixation Trial Liner Placement Dome Plug Insertion Liner Placement X-linked Poly Liner Removal Ceramic / Metal Liner Removal Technique Overview Ordering Information PROCOTYL O Cups RIM-LOCK Ceramic Liners RIM-LOCK Metal Liner RIM-LOCK X-linked Poly Liner BIOLOX Delta Heads CoCr Super Finish Heads Screws Instrumentation PROCOTYL O Acetabular Cup System Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. PROFEMUR Total Hip System

32 Design Rationale chapter The ProcOTYl O acetabular component is a hemi-spherical design. It has a flattened polar region to facilitate easier seating of the component. Initial stability is obtained by the scratch-fit of the plasma sprayed porous titanium layer in combination with the 2 equatorial fins. The porosity of the 400 micron titanium layer varies between 20 and 65%, thereby providing a well-accepted matrix for bone in-growth, resulting in long term fixation. In case initial stability is limited up to 3 screws can be used for extra fixation. Components are available in 2 styles: with and without an additional layer of hydroxylapatite with an average thickness 80 micron. Intra-operative flexibility - PROCOTYL O Acetabular Cup System is the only system on the market which accepts ceramic, metal and A-Class advanced X-linked poly liners. Liners are securely locked by the RIM-LOCK fixation system and the 8 internal taper. PROCOTYL O acetabular components are recommended to be used in conjunction with PROFEMUR femoral components and their unique Modular Neck system. The 3 in-line screw holes are positioned away from the dome of the cup to achieve a maximum lever arm, optimal purchase in the illiac wing and thereby maximizing stability. The screws have a 200 freedom of direction. Modular Necks allow for optimal restoration of patient s original hip biomechanics. Independent of the femoral shaft position, it allows control over leg length, offset, alignment and version. X-ray courtesy of Dr. E. Tozzi, Pisa-Calambrone, Italy 2 PROCOTYL O Acetabular Cup System

33 Design Features of the PROCOTYL O Cup Ordering Information Templates PTC4CL0E 00 Lip Liner Surgical Technique Instruments Implants PTC4CL02E 50 Lip Liner EH E APH04400 POPCKITA non coated cups POHAKITA HA-coated cups CERAKITB ceramic liners XLINKITB poly liners METAKITB metal liners SUFIKITA metal heads CERAKITA ceramic heads Secure initial stability Additional screw fixation In-growth surface 20-65% Porosity 400 µm thickness Plasma sprayed Titanium powder Increase ball bearing diameters 46mm cup - 32mm head 52mm cup - 36mm head Outer geometry Hemi-spherical - Single radius 80 2 Equatorial fins Flattened dome Comes in sizes (2 mm increments) A-Class Advanced X-linked Poly liner 00 and 50 lip options 3600 lip position 28, 32 and 36mm inside diameters PROCOTYL O cup accommodates 3 types of liners Ceramic liner Alumina Matrix composite 00 lip Standard offset Taper locking 28, 32 and 36mm inside diameters Metal liner Cobalt Chrome 00 lip Standard offset Taper locking 28, 32 and 36mm inside diameters PROCOTYL O Acetabular Cup System 3

34 Pre-operative Planning chapter 2 Pre-operative Planning Pre-operative assessment of the appropriate size and position of the acetabular component will provide intra-operative guidance for acetabular reaming. A bilateral A/P x-ray of the pelvis will aid in leg length and offset assessment and management. Leg length discrepancies should be determined pre-operatively and addressed intra-operatively. Radiographic overlays for the PROCOTYL O Acetabular Cup System are available in 5% magnification, with 0 or 5 liners. To determine the acetabular cup size and position, place the overlay outline at approximately 45 of abduction and the center of rotation within the anatomic center of the acetabular image. Note: The use of a magnification marker will aid in determining the x-ray magnification. Caution: Pre-operative templating is intended for estimation purposes only. Final component size and position should be determined intra-operatively. 4 Chapter 2 Pre-operative Planning

35 Surgical Technique chapter 3 Preparation of the Acetabulum Osteophytes should be removed to enable assessment of the true acetabular rim. Reaming should be sequential and start with the smallest reamer that conforms to the acetabular cavity. Reaming to the edge of the reamer will mimic a full hemisphere. Gradually enlarge the acetabulum by reaming articular cartilage until a continuous surface of cancellous bone is exposed. Note: PROCOTYL O shells come in 2mm increments, ranging from mm. Ream to the size of the final component will provide a 0.5mm overall press-fit. Reaming depth, acetabular shape and size can be confirmed by using a trial shell sizer. Chapter 3 Surgical Technique 5

36 PROCOTYL O Cup Reaming Guide For hemispherical press-fit of mm ream to 2mm ream to PROCOTYL O size 42 42mm 4mm PROCOTYL O size 44 44mm 43mm PROCOTYL O size 46 46mm 45mm PROCOTYL O size 48 48mm 47mm PROCOTYL O size 50 50mm 49mm PROCOTYL O size 52 52mm 5mm PROCOTYL O size 54 54mm 53mm PROCOTYL O size 56 56mm 55mm PROCOTYL O size 58 58mm 57mm PROCOTYL O size 60 60mm 59mm PROCOTYL O size 62 62mm 6mm PROCOTYL O size 64 64mm 63mm PROCOTYL O size 66 66mm 65mm PROCOTYL O size 68 68mm 67mm A trial shell adapter (APA0930) is put onto the tip of the cup inserter instrument before mounting the trial shell which corresponds with the final reamer. The adapter is kept in place by a locking ring; the shell is fixed by turning the central rod of the cup inserter clockwise. Following trialing the shell and adapter are to be removed from the cup inserter instrument. Note: The trial shells are equal in dimensions to the corresponding final implant but without fins or plasma coating. 6 Chapter 3 Surgical Technique

37 Inserting the Shell A full series of cup size dedicated adapters (APA APA09309) is available in the instrument kit. The adapter corresponding to the preferred cup size is put onto the tip of the cup impactor, followed by the acetabular component. The pins on both arms of the adapter are to match the dimples in the face of the cup. This method of stabilization provides full control over the position of the cup at impaction. Note: The face of the shell has three laser marked lines that correspond to the screw hole locations. Position the marks between the plane of the anterior-superior and the anterior-inferior iliac spine. Seat the shell with a series of firm mallet blows on the end of the impactor. Once seated, the cup inserter instrument can be removed by turning the central rod counter-clockwise. Complete seating of the implant can be confirmed through the apical hole. Chapter 3 Surgical Technique 7

38 Inserting the Shell (continued) Screw placement can begin once the shell component is securely positioned and the impactor is removed. In case re-positioning of the cup is required, the cup inserter instrument can be mounted again and the cup can be removed, re-oriented and re-implanted. If a deeper seating is preferred, it might help to attach the cup impactor tip to the universal rod and use this as a cup inserter device. The flat of the cup impactor tip is to be positioned properly against the flat of the cup dome before hitting the universal handle with a hammer. Two alignment rods (APA09302) can be mounted on the inserter to aid in positioning the implant at 45 of abduction and 5 of ante-version. Position the longitudinal guide rod 90 to the midline of the patient to position the shell at 45. Position the transverse guide rod parallel to the midline of the patient as this will place the implant at 5 of inclination. Positions given are based on a posterior approach / affected side up. Note: The patient might have shifted during surgery and the alignment rods can therefore only be seen as an orientation guide. 8 Chapter 3 Surgical Technique

39 Screw Placement and Fixation PROCOTYL O shells are designed to allow additional fixation by means of screws; the shells come pre-plugged except for size 42 mm shell. Determine screw location and select a suitable length drill bit. Drill bits are provided in 3.2 and 4.5mm diameters; the drill guide is also available in 3.2 and 4.5mm diameters. Insert the drill into the guide and carefully drill through the acetabular cortex. Use the screw depth gauge to determine the appropriate screw length. Caution: Due to intra-pelvic vascular structures, screw placement in the medial aspect of the acetabulum must be carefully considered. Chapter 3 Surgical Technique 9

40 Grasp the screw head with the screw holding forceps and utilize the hex screwdiver to orient and fixate the screw. Centralize the screw to protect the threads from abrasion and assures countersinking of the screw head within the hole. Release the screw holding forceps to allow for countersinking of the screw head, which allows full seating of the prosthetic liner. Full seating of the liner can be confirmed with the use of a trial liner prior to impacting the prosthetic liner, or by manually examining the inner surface of the shell to check if the screw head is proud. Caution: To ensure proper prosthetic liner seating in the shell, all screw heads must be seated below the inner surface of the shell. Full and unobstructed seating is crucial to implant fit and longevity. Trial Liner Placement Trial liners that match the prosthetic implant are available to evaluate the optimum position of the implant and the preferred liner. With the prosthetic shell secured within the reamed cavity, insert the trial liner into the shell. 0 Chapter 3 Surgical Technique

41 Note: Care should be taken to avoid neck / liner impingement in all potential positions. The acetabular component should be repositioned as necessary to relieve impingement. Alternatively, a change of modular neck could possibly solve the impingement phenomenon. Position the trial liner in the desired orientation and secure it with the captured screw using a 3.5mm hex screwdriver. If a lipped liner is to be used, a reference mark should be made on the acetabulum to aid in proper positioning of the final liner implant. Note: The hard-on-hard liners allow for larger bearing diameters than polyethylene liners, which causes an overlap in the femoral head size range. The difference between group C 28/32 and group E 32/36 is made clear by trial liner colour coding. Chapter 3 Surgical Technique

42 Dome Plug Insertion After a satisfactory trial reduction and assessment of joint stability, seal the dome hole with the special plug. Whereas the screw hole plugs are pre-mounted, the dome hole plug comes separate in the packaging (except size 42 mm). The plug can be attached to the tip of the straight hex driver shaft and will be kept in place by the retaining mechanism. Note: The dome hole plug should not be inserted until a trial reduction with the trial liner is completed. Liner Placement Assemble a 0 or 5 lipped liner positioner to the impactor handle. Place the liner and hold it by hand. Place the liner in the selected position making sure the face of the liner is parallel to the face of the shell. Apply a series of firm mallet blows to fully seat the liner, followed by removal of the inserter. 2 Chapter 3 Surgical Technique

43 Caution: Improper position and impaction of the liner will damage the liner. Hard-on-hard bearing liners are inserted by hand. The inserter handle with mounted liner positioner is applied and fixation is achieved by some light taps. Note: Make sure that the rim of the liner is circumferentially flush with the face of the shell before final seating. Chapter 3 Surgical Technique 3

44 X-linked Poly Liner Removal To remove a poly liner, a flexible drill bit with an acetabular drill guide is used to drill a hole slightly off center from the liner apex. Using a 3.5mm hex screwdriver, a cancellous screw (20mm) is then advanced into the drilled hole until the liner is removed. Ceramic / Metal Liner Removal To remove a ceramic or metal liner a liner extractor is used. Position the tip of the liner extractor in a dimple in the face of the cup and apply some short mallet strokes. This results in a counteraction loosening the liner; repetitive action might be necessary. 4 Chapter 3 Surgical Technique

45 Technique Overview. Preparation of the Acetabulum - reaming. Preparation of the Acetabulum - trial shell to check reamed cavity 3. Inserting the Shell 4. Screw Placement - drilling 5. Screw Placement - fixation 6. Trial Liner Evaluation 7.Trial Liner Insertion 8. Dome Plug Insertion 9. Liner Placement Liner Options: XLPE 00 and 50 Ceramic Metal Chapter 3 Surgical Technique 5

46 Ordering Information Appendix A PROCOTYL O Cups POPCKITA Catalog# Cup Size Inner Ø Group Equatorial Diameter Sph. R Height PHA * 35 A PHA B PHA C PHA C PHA D PHA E PHA E PHA F PHA F PHA G PHA G PHA G PHA G PHA G * Does not possess screw / dome hole plugs PROCOTYL O HA Coated Cups POHAKITA Catalog# Cup Size Inner Ø Group Equatorial Diameter Sph. R Height PHA * 35 A PHA B PHA C PHA C PHA D PHA E PHA E PHA F PHA F PHA G PHA G PHA G PHA G PHA G * Does not possess screw / dome hole plugs 6 Appendix A Ordering Information

47 RIM-LOCK Ceramic Liners CERAKITB Catalog # Group Head Diam. Cup Size PHA04502 A PHA04504 B 44 PHA04506 C PHA04508 D 50 PHA0450 E PHA0452 F PHA0454 G RIM-LOCK Metal Liners METAKITB Catalog # Group Head Diam. Cup Size PHA04702 A PHA04704 B 44 PHA04706 C PHA04708 D 50 PHA0470 E PHA0472 F PHA0474 G RIM-LOCK X-linked Poly Liners XLINKITB 50 Lip 00 Lip Group Head Diam. Cup Size PE at the dome in mm PE at 450 in mm PHA04654 PHA04604 B PHA04656 PHA04606 C PHA04658 PHA04608 D PHA04660 PHA0460 E PHA04662 PHA0462 F PHA04664 PHA0464 G Appendix A Ordering Information 7

48 BIOLOX Delta Head CERAKITA Catalog # Size PHA mm PHA mm PHA mm PHA mm PHA mm PHA mm PHA mm PHA mm PHA mm CoCr Super Finish Head SUFIKITA Catalog # Size mm mm mm mm mm mm mm mm mm mm mm mm Titanium Cancellous Screws 6.5mm Ø / 3.5mm hex Catalog # Length Catalog # Length mm mm mm mm mm mm mm mm 8 Appendix A Ordering Information

49 Instrumentation APH04400 Appendix B Cup Impactor Orientation Rod Trial Cup Impactor Adapter Cup Impactor Adapter Group A - B - C - D - E - F - G Trial Acetabular Cup Sizes RIM-LOCK Trial Liners 50 Lip RIM-LOCK Trial Liners 00 Lip Poly Liner Positioners Ø Poly Lipped Liner Positioners Ø Ceramic and Metal Liner positioners Ø Final Cup Impactor Tip Ceramic / Metal Liner Extractor Tommy Bar Universal handle for liners positioner Appendix B Instrumentation 9

50 Screw holder Drill bits Hex driver shaft straight solid 3.5mm Universal joint 3.5mm hex driver shaft Flexible drill / screw shaft Flexible screw depth gauge Ratchet screwdriver handle with quick connection Fixed angle drill guide 3.2mm / 4.5mm 20 Appendix B Instrumentation

51 PROCOTYL O Instruments APH04400 Note: Reamers are not included in the PROCOTYL O instruments set. Catalog # Description Quantity PTC4CL0E X-ray templates 5% magnification 00 lip liner PTC4CL02E X-ray templates 5% magnification50 lip liner FNA00470 Sterilization container (empty) FNA00473 Lid for tray APA0930 Cup impactor APA09302 Orientation rod 2 APA0930 Trial cup impactor adapter APA09303 APA09304 APA09305 APA09306 APA09307 APA09308 APA09309 APA09322 APA09324 APA09326 APA09328 APA09330 APA09332 APA09334 APA09336 APA09338 APA09340 APA09342 APA09344 APA09346 APA09348 Cup impactor adapter group A Cup impactor adapter group B Cup impactor adapter group C Cup impactor adapter group D Cup impactor adapter group E Cup impactor adapter group F Cup impactor adapter group G Trial acetabular cup size 42 Trial acetabular cup size 44 Trial acetabular cup size 46 Trial acetabular cup size 48 Trial acetabular cup size 50 Trial acetabular cup size 52 Trial acetabular cup size 54 Trial acetabular cup size 56 Trial acetabular cup size 58 Trial acetabular cup size 60 Trial acetabular cup size 62 Trial acetabular cup size 64 Trial acetabular cup size 66 Trial acetabular cup size 68 FNA0047 Sterilization container 2 (empty) FNA00474 Lid for tray 2 PPB3902 Tommy bar PPR68030 PPR68038 APA04565 APA0933 Universal handle for: Poly standard / lipped liner positioner Ceramic / metal liner positioner Ceramic / metal liner positioner ø 28 Ceramic / metal liner positioner ø 32 Ceramic / metal liner positioner ø 36 Appendix B Instrumentation 2

52 Catalog # Description Quantity APA07054 APA07056 APA093 Poly liner positioner ø 28 Poly liner positioner ø 32 Poly liner positioner ø 36 APA07060 APA07062 APA0932 Poly lipped liner positioner ø 28 Poly lipped liner positioner ø 32 Poly lipped liner positioner ø 36 APA09382 APA09384 APA09386 APA09388 APA09390 APA09392 APA09394 APA09396 APA09398 RIM-LOCK Trial liner 00 lip 28 Group A RIM-LOCK Trial liner 00 lip 28 Group B RIM-LOCK Trial liner 00 lip 28 Group C RIM-LOCK Trial liner 00 lip 32 Group C RIM-LOCK Trial liner 00 lip 32 Group D RIM-LOCK Trial liner 00 lip 32 Group E RIM-LOCK Trial liner 00 lip 36 Group E RIM-LOCK Trial liner 00 lip 36 Group F RIM-LOCK Trial liner 00 lip 36 Group G APA09364 APA09366 APA09368 APA09370 APA09372 APA09374 RIM-LOCK Trial liner 50 lip 28 Group B RIM-LOCK Trial liner 50 lip 28 Group C RIM-LOCK Trial liner 50 lip 32 Group D RIM-LOCK Trial liner 50 lip 32 Group E RIM-LOCK Trial liner 50 lip 36 Group F RIM-LOCK Trial liner 50 lip 36 Group G APA0934 Ceramic / Metal liner extractor PPR68070 Final cup impactor tip FNA00472 Sterilization container 3 (empty) FNA00475 Lid for tray SH0000 Screw holder 8400DG0 Fixed angle drill guide 3.2mm / 4.5mm 8400FD0 Flexible drill / screw shaft 8400FD FD FD FD QCRH Drill bit 3.2 x 25mm Drill bit 3.2 x 35mm Drill bit 4.5 x 25mm Drill bit 4.5 x 35mm Ratchet screwdriver handle with quick connection 8400SD03 Universal joint 3.5mm hex driver shaft 8400SD06 Hex driver shaft straight solid 3.5mm 8400SG0 Flexible screw depth gauge 22 Appendix B Instrumentation

53 Notes 23

54 24 Notes

55

56 Wright Medical Technology, Inc Airline Road Arlington, TN phone toll-free Wright Medical EMEA Krijgsman 86 DM Amstelveen The Netherlands phone Trademarks and Registered marks of Wright Medical Technology, Inc. Patents pending. 200 Wright Medical Technology, Inc. All Rights Reserved. EH E Rev 02

57 PROCOTYL C Cemented Acetabular Cup System Hemispherical design Circumferential fixation grooves Radiological marker

58

59 Design Overview Preface PROCOTYL C Cemented Acetabular Cup System» Hemispherical design» A-Class Advanced Cross-Linked Poly» Circumferential fixation grooves» Radiological marker» Large range of motion PROCOTYL C Implant Cup Size Head Size PHA PHA PHA PHA PHA PHA PHA PHA PHA PHA PROCOTYL C Cemented Acetabular Cup System

60 Surgical Technique chapter Preparation of the acetabulum Following the preferred surgical exposure, the acetabular cavity is reamed with hemispherical reamers, preferably with 2 mm increments. The direction of the reaming is supero-posterially. Avoid over reaming. Increase reamer size until contact is made with the anterior and posterior wall. Multiple small anchoring holes drilled into the subchondral bone will enhance fixation. The acetabular component and acetabular trial component size match the size of the last acetabular reamer. Fix the trial cup to the inserter handle. Slide the aiming device over the handle of the inserter instrument and screw the anteversion rod into the left of the right screw hole - operated size depending. Insert the trial cup into the acetabulum. With the aiming device as illustrated. The rim of the trial cup will be orientated at 200 of anteversion and 450 of inclination Figure Check that the edge of the cup is now flush with or within the acetabular rim Figure 2 Figure Figure 2 2 Chapter Surgical Technique

61 Cementing of the acetabular component After trial insertion, the acetabulum is cleaned The cup inserter handle must be prepared for cup placement. Screw the cup pusher head onto the instrument, followed by the 32 or 36 mm hemispherical positioning hat Figure 3 Depending on the surgeon s preference for a specific cement mantle thickness a cup size is chosen. The sizes of the cups are in nominal value. Figure 3 The bone cement is handled in the preferred manner and the cement is applied into the acetabulum. The cup is inserted into the doughy cement mass and pushed down to the preferred level Figure 4. Excess cement will escape when the cup is driven home and needs to be removed. Hold the cup stable and remove the inserter. Remove the positioning hat and reapply the inserter into the cup Figure 5 Hold still and maintain applying pressure onto the cup until the cement has fully set. Note: The technique shown above illustrates a posterior approach. Figure 5 Figure 4 Chapter Surgical Technique 3

62 Ordering Information chapter 2 PROCOTYL C Implants» Material: A-Class Advanced Cross -Linked Poly» Sterilization: Ethylene Oxide» Packaging: Double blister Catalogue # Cup Size Head Size PHA PHA PHA PHA PHA PHA PHA PHA PHA PHA Chapter 2 Ordering Information

63 Instrumentation chapter 3 PROCOTYL C Instruments APH04500 Catalogue # Description Quantity APA002 Cup Inserter Handle APA004 Cup Inserter Handle Guide APA006 Orientation rod APA008 Cup positioning hat ø 32 APA00 Cup positioning hat ø 36 APA02 Cup pusher head ø 26 APA06 APA08 APA020 APA022 APA024 APA026 APA028 APA030 APA032 APA034 APA036 APA038 PROCOTYL C Trial Cup Size 46 PROCOTYL C Trial Cup Size 48 PROCOTYL C Trial Cup Size 50 PROCOTYL C Trial Cup Size 52 PROCOTYL C Trial Cup Size 54 PROCOTYL C Trial Cup Size 56 PROCOTYL C Trial Cup Size 58 PROCOTYL C Trial Cup Size 60 PROCOTYL C Trial Cup Size 62 PROCOTYL C Trial Cup Size 64 PROCOTYL C Trial Cup Size 66 PROCOTYL C Trial Cup Size 68 PCCCL02E PROCOTYL C Templates 5% Chapter 3 Instrumentation 5

64 Wright Medical Technology, Inc Airline Road Arlington, TN phone toll-free Wright Medical EMEA Krijgsman 86 DM Amstelveen The Netherlands phone Trademarks and Registered marks of Wright Medical Technology, Inc. Patents pending Wright Medical Technology, Inc. All Rights Reserved. EH E Rev0

65

66 A-CLASS Cross-Linked Polyethylene Wear Less. No Oxidation The A-CLASS finishing process utilizes Ethylene Oxide (EtO) sterilization to maintain the oxidative stability of polyethylene. EtO does not add free radicals to polyethylene EtO sterilization preserves oxidative stability in the material Oxidation Analysis of Aged Wear Test Components: Oxidation index was measured on 3 A-CLASS 28mm liners (5 million cycles wear) Components were aged in air for over 3 years Oxidation profiles conducted at high stress points. No detectable oxidation! 2 Undetectable Free Radicals Wright s A-CLASS Polyethylene manufacturing process utilizes remelting to quench free radicals and increases cross-link density. Cross-linking process balances improved wear and strength properties. Remelting removes more free radicals than below-themelt-annealing 3 92% or Greater Reduction in Wear Compared to Conventional Polyethylene Wear (mm 3 ) Conventional Poly A-CLASS Cross-Link Polyethylene. Kurtz, CORR, Vol 453: Data on file at Wright. 3. Gomez-Barrena, Acta Orthopaedica, Vol. 79, No. 6, Pages Million Cycles Laboratory testing confirms a 92% reduction in wear or greater for A-CLASS Cross-Linked Polyethylene compared with Wright conventional Polyethylene (Data on file at Wright) Wright Medical Technology, Inc Airline Road Arlington, TN phone toll-free Trademarks and Registered marks of Wright Medical Technology, Inc Wright Medical Technology, Inc. All Rights Reserved. Wright Medical EMEA Krijgsman 86 DM Amstelveen The Netherlands MH