Total Wrist System. Surgical TEchniquE Maestro. Surgical Technique. Optional additional Descriptor Optional additional Descriptor

Transcription

1 Surgical TEchniquE Maestro Total Wrist System Surgical Technique Optional additional Descriptor Optional additional Descriptor Knees Hips Extremities Cement and Accessories PMI Technology

2 Maestro Total Wrist System Figure 1 Preoperative Planning and Surgical Approach After the surgeon and patient have decided to proceed with total wrist arthroplasty, the surgeon should conduct preoperative planning using the templates provided and identify approximate sizes for each of the following components: Radial body Radial stem Capitate stem Carpal plate Carpal head Radial and ulnar screws The patient is positioned supine on the operating table with the extremity placed comfortably on a hand table. Apply the pneumatic tourniquet to the upper arm and exsanguinate with an Esmarch bandage (Figure1). Total wrist arthroplasty can be performed under general or regional anesthesia based on surgeon preference. Additionally, the administration of antibiotics is by preference of the surgeon and individualized to the patient. Inflate the pneumatic tourniquet. Estimate the amount of distal radius to be resected. This brochure is presented to demonstrate the surgical technique utilized by: James W. Strickland M.D., Andrew K. Palmer M.D., and Thomas J. Graham M.D. Biomet, as the manufacturer of this product, does not practice medicine and does not recommend this or any other system for use on a specific patient. The surgeon who performs any procedure is responsible for determining and utilizing the appropriate techniques for such procedure for use on a specific patient. Biomet is not responsible for selection of the appropriate surgical technique or products to be utilized for an individual patient.

3 Figure 2 Figure 3 Incision and Approach Total wrist arthroplasty is performed through a dorsal incision placed slightly radial to the center of the hand and wrist and extending from three to four centimeters proximal to the distal radius to half way up the third metacarpal (Figure 2). Dissect directly to the dorsal retinaculum without excessive undermining. Palpate Lister s Tubercle and open the third dorsal extensor compartment, exposing the extensor pollicis longus tendon (EPL) (Figure 3). 1

4 Maestro Total Wrist System Figure 4 Figure 5 Mobilize the EPL proximally and distally and displace it radially. Expose the dorsal wrist capsule and make a longitudinal capsular incision extending from the distal radius to the base of the third metacarpal (Figure 4). Dissecting sharply against the underlying radius and carpus, elevate the overlying extensor compartments radially and ulnarward without violating their undersurface. Elevation and protection of the first dorsal compartment tendons and the brachioradialis off the radius is also recommended. Carpal Resection Guide Assembly With the capitate and the proximal aspect of the third metacarpal exposed to facilitate alignment, the carpal resection guide is positioned so that the proximal apex of the guide allows visualization and subsequent resection of 2 3 mm of the capitate head (Figure 5). Homan or large Gelpi retractors are used to displace the ulnar capsule and extensor tendons ulnarward and the radial capsule and radial wrist extensors, EPL, and first compartment tendons radially, exposing the distal radius, the radioulnar joint capsule, the entire carpus, and the metacarpal bases. 2

5 Figure 6 Figure 7 Two.062" K-wires are inserted through the guide the first wire is placed at the level of the capitate neck and the second in the metaphysis of the third metacarpal with the guide parallel to the longitudinal axis of the third metacarpal (Figure 6). If properly placed, the ulnar wing of the guide should line up closely with the midcarpal articulation between the triquetrum and the hamate, while the radial wing bisects the scaphoid in its distal third. Radial Scoring Fully loosen thumbscrew and insert the arm of the radial resection level guide into the slot on the carpal resection guide (Figure 7). Position the slot over the center of the radius and tighten the thumbscrew. 3

6 Maestro Total Wrist System Figure 8 With the wrist in a neutral position, use a 5 mm sawblade to score the center surface of the radius through the cutting slot (Figure 8). This will serve as a landmark for resection level of the distal radius later in the procedure. Note: The carpal resection guide handle shown in Figure 9 may be used to assist positioning. 4

7 Figure 9 Figure 10 Carpal Resection Remove the radial resection level guide and insert the carpal resection guide handle to help stabilize carpal guide during resection. Keeping the sawblade flush against the four edges of the carpal resection guide, cut through the scaphoid, capitate head, edge of the hamate, and triquetrum (Figures 9 and 10). Note: There are multiple scaphoid augment sizes, which may assist in the determination of how much scaphoid is removed. 5

8 Maestro Total Wrist System Figure 12a Figure 11 Figure 12 Carpal Canal Preparation Remove the carpal resection guide and remove the K-wires with either the K-wire Driver or the pin puller (Figure 11). Using a knife and ronguer, remove the proximal carpus and remaning distal scaphoid fragments (Figure 12). Insert a K-wire into the capitate at the apex of resection. The entry point should be placed in the center of the capitate. Confirm positioning with the aid of fluoroscopy (Figure 12a). 6

9 Figure 13 Figure 14 The 6 mm cannulated capitate reamer is placed over the K-wire and carefully used to ream the center of the capitate without cracking the cortical walls (Figure 13). Fluoroscopy should be used to determine the reamer placement, depth, and size within the capitate. The flutes and stem should be inserted until they near the distal surface of the capitate. The appropriate size trial capitate stem will be determined by the blue and green depth marks at the proximal margin of the capitate and fluoroscopic confirmation of the position of the reamer (Figure 14). If only the flutes are inserted past the articular surface, the silver trial (6 x12 mm) is used. A 7.5 mm capitate reamer can be used for large capitates and will require a cement mantle. 7

10 Maestro Total Wrist System Figure 15 Carpal Trial Placement At this point, the reamer and K-wire are withdrawn from the capitate. The trial carpal plate is provisionally determined by the curvature and width of the proximal carpal surface and the size of the radial defect resulting from the removal of the entire scaphoid. Carpal plates are available in lengths of 37 mm and 43 mm with three separate scaphoid augment options for each length. In most instances, there is a radial defect proximal to the base of the trapezoid and one of the augmented carpal plates should be used. The appropriate carpal plate should lie flush with the hamate and proximal capitate surfaces. The scaphoid augment should hug the radial slope of the capitate and the base of the trapezoid. Assemble the previously chosen capitate stem trial to the appropriate carpal plate trial. The assembled carpal plate and stem trial are then inserted onto the proximal carpal surface and into the capitate using the insertion tool (Figure 15). When fitted correctly, the radial screw hole should lay straight below the second metacarpal, and the ulnar screw hole should be positioned so that an angled screw will be centered in the hamate. Any protruding bone that impedes congruous fitting of the carpal plate should be trimmed. Trial fitting of the carpal plates together with the predetermined capitate stem and various radial augments is continued until observation and fluoroscopy confirms satisfactory plate position, radial augment size, and screw hole alignment. The carpal plate/capitate stem combination is then removed. Note: If a hemi-arthroplasty is being performed, proceed to Carpal Implant Insertion (Figure 32). 8

11 Figure 16 Figure 17 Radial Canal Preparation With the wrist held in near full palmar flexion, the entire distal articular surface of the radius is visualized. Insert a.062" K-wire into the lower radial corner of the dorsal ulnar quadrant of the scaphoid fossa of the radial articular surface. Fluoroscopic confirmation of the centered position of the K-wire in the radius should be demonstrated before proceeding. Several placements of the K-wire may be required to achieve perfect centering. Drill over the K-wire with the cannulated drill bit (Figure 17). Using these landmarks, the entry point for the K-wire should be near the center of the radius and immediately beneath the ulnar upslope of Lister s Tubercle. The K-wire is then driven straight down the center of the medullary canal of the radius (Figure 16). 9

12 Maestro Total Wrist System Figure 18 Figure 19 Remove the K-wire and ream the radius beginning with the 4.5 mm radial reamer. Continue reaming until the flutes are inserted past the articular surface (Figure 18). With the aid of fluoroscopy, increase the radial reamer size until chatter of the reamer is encountered and the reamer flutes fill the medullary canal of the radius. Radial Resection Guide Assembly Keep the last reamer used in the radial canal and remove the ratcheting handle from the reamer. Attach the radial resection guide boom to the shaft of the reamer. The resection guide is then slid over the boom, and the thumbscrew is tightened to secure the guide on the boom (Figure 19). 10

13 Figure 20 Figure 21 Align the proximal-most margin of the resection guide with the initial score mark made on the dorsal cortex of the radius (Figure 20). Secure the resection guide to the radius using.062" K-wires (Figure 21). 11

14 Maestro Total Wrist System Figure 22 Figure 23 Radial Cuts Remove the reamer and guide boom from the radius, leaving the rounded resection guide secured in place by the K-wires (Figure 22). Transect the radius along the proximal edge of the guide while keeping the blade flush against the arc of the guide (Figure 23). The contour of the radial resection guide directs the saw cut to exit at the juxta-articular margin of the radius platform and Distal Radial Ulnar Joint (DRUJ) thus maintaining the native anatomy on the ulnar side. Complete the distal radial cut, remove the K-wires and the radial resection guide. Care should be taken when dissecting the distal fragment from the soft tissues including the pronator quadratus. 12

15 Figure 24 Figure 25 Radial Broaching Based on the last radial reamer size used, insert the corresponding radial IM guide into the radial canal (Figure 24). Attach the appropriate chisel guide to the modular handle. Select the chisel guide based on distal radius width. Slide the chisel guide onto the radial IM guide until flush with the resected surface, ensuring proper orientation (lettering is always dorsal). If the chisel guide surface does not fit flush with the distal radius, trim any prominent or protruding bone to achieve a totally congruous fit. Insert the appropriate size chisel into the chisel guide, tapping on the chisel until it is fully seated (Figure 25). Repeat on the other side of the chisel guide. 13

16 Maestro Total Wrist System Figure 26 Figure 27 Remove the chisel, chisel guide, and IM guide. Clean any remaining bone fragments from the chiseled triangular entrance into the distal radius (Figure 26). Re-insert the IM guide into the medullary canal of the radius. Place the radial broach over the radial IM guide, ensuring proper orientation. Tap the broach until the cutting teeth are fully inserted (Figure 27). 14

17 Figure 28 Figure 29 Trial Component Placement Step 1 Assemble the previously fitted capitate stem trial and carpal plate, and insert into the previously prepared carpus (Figure 28). Step 2 Select the appropriate radial stem and body trial for assembly. The radial stem size is based on the size of the last radial reamer used. The distal radial component trial is based on the size of the broach used to prepare the entrance into the distal radius. Connect the radial stem and radial body and then insert into canal opening (Figure 29). Tap into place with the radial impactor until flush with the distal radius surface. 15

18 Maestro Total Wrist System Figure 30 Figure 31 Step 3 Place the wrist in full flexion. Be sure that the carpal plate remains properly oriented and flush with the carpal surfaces. Snap fit the standard size carpal head to the carpal plate (Figure 30). Distract the wrist slightly and extend the hand to articulate the two components. Trial Reduction With all retractors removed, evaluate the motion and stability of the wrist. Approximately 2 3 mm of joint separation should be possible during modest distraction (Figure 31). If the wrist components are deemed to be too loose, replace the standard size carpal head with a +2 or +4 size head. Retest until the desired motion and stability under distraction are achieved. Satisfactory radial and ulnar deviation, flexion and extension of the wrist should be demonstrated at this point. Fluoroscopy should be used to further confirm the positioning of the two components. If soft tissue tension is too tight, further resect the radius. If the radial component will impinge the distal ulna, or if degenerative damage was present on preoperative x-rays, excise the distal ulna in a Darrach fashion. 16 Remove all trials from the wrist and irrigate with normal saline.

19 Figure 32 Figure 33 Figure 34 Carpal Implant Insertion Assemble the appropriate capitate stem to the carpal plate using the assembly tool and driver (Figure 32). Inject bone cement into the cavities of the capitate. Insert the distal component pressing the stem into the capitate and the plate against the distally resected carpus using the carpal plate impactor. Select the appropriate drill guide (fixed or variable based upon screw preference) and connect the guide to the ulnar threaded hole of the carpal plate. Insert the K-wire sleeve into the drill guide, and under fluoroscopy, place the K-wire through the inner sleeve and into the bone. The pin will be directed obliquely into the central part of the hamate (Figure 33). When the desired placement of the K-wire is found using fluoroscopy, remove the K-wire sleeve and place the cannulated drill bit over the K-wire. Drill depth will be based upon desired screw length and confirmed with fluoroscopy. Screw length is based on drill depth referenced on the cannulated drill bit with respect to the proximal end of the drill guide. This process is repeated on the radial side, with the K-wire and drill inserted longitudinally through the trapezoid and into the second metacarpal (Figure 34). 17

20 Maestro Total Wrist System Figure 35 Figure 36 After both holes are drilled, insert the appropriate size ulnar and radial screws, making certain they are fully seated and locked into the carpal plate (Figure 35). Place the carpal head onto the taper of the carpal plate and impact, ensuring that the groove of the head is parallel with the length of the plate (Figure 36). 18

21 Figure 37 Figure 38 Radial Implant Insertion Assemble the radial stem to the radial body using the implant assembly tool (Figure 37). Inject bone cement into the radial cavity. Place the appropriate size radial component in the canal and use the radial impactor to ensure it is fully seated. Articulate the wrist and confirm proper positioning of the components radiographically (Figure 38). 19

22 Maestro Total Wrist System Figure 39 Closure Close the wrist capsule and dorsal retinaculum using nonabsorbable sutures and close the skin in the customary manner (Figure 39). The EPL may be left repositioned radially or included in the repair of the retinaculum and the use of a drain is at the discretion of the surgeon. If the distal ulnar was excised, a strong, stabilizing capsular closure should be carried out over the distal ulnar stump. Apply a sterile bulky dressing incorporating a palmar splint. Deflate the pneumatic tourniquet. Prior to removing the drapes and awakening the patient use flouroscopy to confirm that the implant remains in a reduced position. Post-Operative Early finger motion is encouraged. Remove the splint at one week and apply a cast or splint for an additional one to three weeks. Note: If the distal ulna was removed, the forearm should be splinted in neutral rotation for three weeks before commencing rotational exercises. Any drains are removed at 24 hours. The dressing and sutures are removed at days. If the distal ulna was preserved, a short arm, removable splint is fashioned to maintain the wrist in neutral. Gentle active motion is permitted several times daily with the splint removed after 14 days. More vigorous active and passive motion are commenced at one month and the frequency of exercises and the amount of passive force applied to the hand is varied according to the patient s progress and the discretion of the surgeon and therapist. 20

23 Implants Product Part Number Description Size Tapered Carpal Plate Tapered Carpal Plate Tapered Carpal Plate Tapered Carpal Plate Tapered Carpal Plate Tapered Carpal Plate Tapered Carpal Plate Tapered Carpal Plate 9 mm x 37 mm 9 mm x 43 mm 9 mm x 37 mm with 6 mm augment 9 mm x 37 mm with 9 mm augment 9 mm x 37 mm with 12 mm augment 9 mm x 43 mm with 8 mm augment 9 mm x 43 mm with 11 mm augment 9 mm x 43 mm with 14 mm augment Carpal Head Carpal Head Carpal Head Captitate Stem Captitate Stem Captitate Stem 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Fixed Locking Screw 4.75 mm Variable Locking Screw 4.75 mm Variable Locking Screw 4.75 mm Variable Locking Screw 4.75 mm Variable Locking Screw 4.75 mm Variable Locking Screw 4.75 mm Variable Locking Screw 4.75 mm Variable Locking Screw 4.75 mm Variable Locking Screw Radial Body Left Radial Body Right Radial Body Left Radial Body Right Radial Stem Radial Stem Radial Stem Radial Stem STD 2 mm 4 mm 12 mm 15 mm 18 mm 15 mm 20 mm 25 mm 30 mm 35 mm 40 mm 45 mm 50 mm 15 mm 20 mm 25 mm 30 mm 35 mm 40 mm 45 mm 50 mm 7.5mm 7.5 mm 9.0 mm 9.0 mm 4.5 mm 6.0 mm 7.5 mm 9.0 mm 21

24 Maestro Total Wrist System Instruments Product Part Number Description Size Pin Puller Carpal Resection Guide Resection Guide Handle Resection Level Guide Radial Resection Guide Radial Resection Guide Boom Cannulated Capitate Reamer Cannulated Capitate Reamer Radial Reamer Radial Reamer Radial Reamer Radial Reamer Radial Reamer 6.0 mm 7.5 mm 4.5 mm 6.0 mm 7.5 mm 9.0 mm 10.5 mm Radial IM Guide Radial Chisel Radial Chisel Radial Chisel Chisel Guide Chisel Guide Chisel Guide 7.5 mm 9.0 mm 10.5 mm 7.5 mm 9.0 mm 10.5 mm Chisel Guide Handle 22

25 Instruments Product Part Number Description Size Carpal Head Trial Carpal Head Trial Carpal Head Trial STD +2 mm +4 mm Radial Broach Screw Hex Driver Radial Provisional Extractor Carpal Provisional Holding Forcep Implant Assembly Tool Radial Impactor Carpal Impactor Carpal Plate Trial Carpal Plate Trial Carpal Plate Trial Carpal Plate Trial Carpal Plate Trial Carpal Plate Trial Carpal Plate Trial Carpal Plate Trial Capitate Stem Trial Capitate Stem Trial Capitate Stem Trial Radial Body Trial Radial Body Trial Radial Body Trial Radial Body Trial 40 mm Radial Stem Trial 40 mm Radial Stem Trial 40 mm Radial Stem Trial 40 mm Radial Stem Trial 9 mm x 37 mm 9 mm x 43 mm 9 mm x 37 mm with 6 mm augment 9 mm x 37 mm with 9 mm augment 9 mm x 37 mm with 12mm augment 9 mm x 43 mm with 8 mm augment 9 mm x 43 mm with 11 mm augment 9 mm x 43 mm with 14 mm augment 6x12 mm 6x15 mm 6x18 mm 7.5 Left 7.5 Right 9.0 Left 9.0 Right 4.5 mm 6.0 mm 7.5 mm 9.0 mm 23

26 Maestro Total Wrist System Instruments Product Part Number Description Size Tapered Carpal Plate Impactor Carpal Head Extractor Fixed Drill Guide Variable Drill Guide K-wire Sleeve Cannulated Drill Bit Hexalobular Driver Impactor Handle Ratcheting Handle 24

27 Biomet Orthopedics East Bell Drive Date: 07/08 P.O. Box 587 Warsaw, Indiana USA MaeStrO WriSt JOiNt replacement SySteM attention OPeratiNG SUrGeON DeScriPtiON Biomet manufactures wrist joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications. Wrist joint replacement components include: multiple piece radial and carpal components, and screws. Materials: Radial Stems Radial Bodies Carpal Heads Carpal Plates Capitate Stems Carpal Screws Surface Coating Titanium Alloy Cobalt Alloy or CoCr/UHMWPE Cobalt Alloy or CoCr/UHMWPE Cobalt Alloy Titanium Alloy Titanium Alloy Titanium Alloy indications total Wrist indications The Maestro Total Wrist and Maestro Wrist Fracture Replacement systems are indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by: 1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Scapholunate Advanced Collapse (SLAC) and other functional deformities. 5. Trauma, including fractures of the distal radius and/or carpal bones. carpal Hemiarthroplasty indications The Maestro Carpal Hemiarthroplasty is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by: 1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Scapholunate Advanced Collapse (SLAC) and other functional deformities. 5. Trauma, including fractures of the carpal bones. The radial and carpal components are intended to be implanted with bone cement. contraindications Absolute contraindications include: infection, sepsis, and osteomyelitis. Relative contraindications include: 1) uncooperative patient or patients 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/or 7) absent or insufficient wrist extensor tendons. WarNiNGS Patient selection factors to be considered include: 1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of activity levels, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity. 1. Improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components. 2. Malalignment of the components or inaccurate implantation can lead to excessive wear and/ or failure of the implant or procedure. Inadequate preclosure cleaning (removal of surgical debris) can lead to excessive wear. Improper preoperative or intraoperative implant handling or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue fracture and/or excessive wear. 3. Thoroughly clean and dry connecting segments prior to attachment of components to avoid improper seating. Use clean gloves when handling implants. Laboratory testing indicates that implants subjected to body fluids, surgical debris or fatty tissue have lower adhesion strength to cement than implants handled with clean gloves. 4. Do not modify implants. 5. The surgeon is to be thoroughly familiar with the implants and instruments, prior to performing surgery. 6. Properly align and securely assemble connecting components. Failure to properly align and completely seat the components together can lead to disassociation. Thoroughly clean and dry all connections prior to attachment of modular components to avoid improper seating. 7. Care is to be taken to assure complete support of all parts of the device embedded in bone cement to prevent stress concentrations that may lead to failure of the procedure. Complete preclosure cleaning and removal of bone cement debris, metallic debris and other surgical debris at the implant site is critical to minimize wear of the implant articular surfaces. Implant fracture due to cement failure has been reported with joint replacement implants. 8. Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients. While these devices are generally successful in attaining these goals they cannot be expected to withstand the activity levels and loads of normal healthy bone and joint tissue. 9. Accepted practices in postoperative care are important. Failure of the patient to follow postoperative care instructions involving rehabilitation can compromise the success of the procedure. The patient is to be advised of the limitations of the reconstruction and the need for protection of the implants from full load bearing until adequate fixation and healing have occurred. 10. Excessive activity, trauma and excessive load bearing have been implicated with premature failure of implants by loosening, fracture, and/or wear. Loosening of the implants can result in increased production of wear particles, as well as accelerate damage to bone, making successful revision surgery more difficult. 11. The patient is to be made aware and warned of general surgical risks, possible adverse effects as listed, and to follow the instructions of the treating physician including follow-up visits. 12. Do not use poly carpal head with any other radial implant other than the Maestro Radial Fracture implant. Wrist joint replacement prostheses have not received FDA clearance for non-cemented application (USA). Maestro Wrist implants have not received FDA clearance for radial-hemiarthroplasty indications. PrecaUtiONS 1. Specialized instruments are designed for Biomet joint replacement systems to aid in the proper implantation of the prosthetic components. The use of instruments or implant components from other systems can result in inaccurate fit, sizing, excessive wear and device failure. Intraoperative fracture or breaking of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments that have experienced extensive use or excessive force are susceptible to fracture. Surgical instruments should only be used for their intended purpose. Biomet recommends that all instruments be regularly inspected for wear and disfigurement. 2. Do not reuse implants. While an implant may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant. Do not treat patients with implants that have been, even momentarily, placed in a different patient. 3. Patient must avoid placing excessive loads on the implant. 4. Patient must avoid lifting more than 5 lbs with the operated arm after surgery. 5. Patient must avoid putting full body weight on the operated arm when rising from a seated position. 6. Patient must avoid sudden or strenuous pushing and/or pulling activities after surgery, as these can produce excessive stress on the operated arm. 7. Patients must avoid full wrist flexion or extension under load bearing conditions. 8. Pay careful attention to possible soft tissue irritation as a result of the volar flange (Maestro Radial Fracture implant only). POSSiBle adverse effects 1. Material sensitivity reactions. Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts. The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid. It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant. 2. Early or late postoperative infection and allergic reaction. 3. Intraoperative bone perforation or fracture may occur, particularly in the presence of poor bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device. 4. Nerve injury is a concern in all joint replacement procedures. 5. Loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity. 6. Periarticular calcification or ossification, with or without impediment of joint mobility. 7. Inadequate range of motion due to improper selection or positioning of components. 8. Undesirable shortening or lengthening of limb. 9. Dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and fibrous tissue laxity can also contribute to these conditions. 10. Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive load bearing. 11. Fretting and crevice corrosion can occur at interfaces between components. 12. Wear and/or deformation of articulating surfaces. 13. Intraoperative or postoperative bone fracture and/or postoperative pain. Sterility Prosthetic components are sterilized by exposure to a minimum dose of 25 kgy of gamma radiation. Do not resterilize. Do not use any component from an opened or damaged package. Do not use implants past expiration date. caution: Federal law (USA) restricts this device to sale, distribution, or use by or on the order of a physician. Comments regarding this device can be directed to Attn: Regulatory Dept., Biomet, Inc., P.O. Box 587, Warsaw, IN 46581, FAX: Biomet and all other trademarks herein are the property of Biomet, Inc. or its subsidiaries. Authorized Representative: Biomet U.K., Ltd. Waterton Industiral Estate Bridgend, South Wales CF31 3XA UK 0086 The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet at the contact information provided herein.

28 All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. This material is intended for the sole use and benefit of the Biomet sales force and physicians. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert herein and Biomet s website. P.O. Box 587, Warsaw, IN x Biomet Orthopedics Form No. BOI REV063009