RENEWING INNOVATIONS. ENDURING SOLUTIONS.

Transcription

1 Operative Technique Ceramic AHS RENEWING INNOVATIONS. ENDURING SOLUTIONS.

2 Table of Contents INTRODUCTION...1 PRE-OPERATIVE PLANNING...3 templating...3 OPERATIVE TECHNIQUE OVERVIEW...4 DETAILED OPERATIVE TECHNIQUE...6 Approach and Exposure...6 Acetabular Reaming...6 Acetabular Trialing...6 Acetabular Shell Implantation...7 Ceramic Liner Trialing...9 Ceramic Liner Insertion...10 Ceramic Liner INSERTION (ALTERNATIVE METHOD) Ceramic Liner Removal (If Needed)...12 Femoral Stem/Femoral Head Preparation...12 POST-OPERATIVE CARE...13 SYSTEM SPECIFICATIONS...14 INSTRUMENT LISTING...16 PACKAGE INSERT...19 NOVATION CERAMIC AHS DESIGN TEAM Wael K. Barsoum, MD Cleveland Clinic Foundation Charles N. Cornell, MD Hospital for Special Surgery Raymond P. Robinson, MD Virginia Mason Medical Center Jerome D. Wiedel, MD University of Colorado

3 INTRODUCTION Like the art of fine woodworking, the Novation Comprehensive Hip System design began with the end in mind. Before launching into development, Exactech s engineers and design team surgeons established a comprehensive plan. Their goal: to provide a system of femoral stems, acetabular components and surgical instrumentation that would address a variety of situations encountered during primary total hip replacement. The Novation Ceramic AHS is a ceramic-on-ceramic articulation hip prosthesis system composed of the following components: Novation Ceramic AHS Plasma-Coated Acetabular Shell Novation Ceramic AHS Alumina Acetabular Liner (BIOLOX forte) Exactech 12/14 Alumina Femoral Head (BIOLOX forte) Exactech 6.5mm Bone Screws (optional) Compatible Exactech 12/14 Femoral Stems This operative technique details the methods for implanting the acetabular components and includes an abbreviated femoral stem preparation section. For complete information on femoral stem preparation, refer to the operative techniques for Exactech s compatible 12/14 taper femoral stem systems. The Novation Ceramic AHS Liners are only compatible with Novation Ceramic AHS Shells and Exactech 12/14 Alumina Femoral Heads. Exactech 12/14 Alumina Femoral Heads are only compatible with the Exactech femoral prostheses listed at the end of this technique. Use of other components (e.g. metal heads, zirconia femoral heads or another manufacturer s components) may accelerate bearing wear and lead to early failure of the system. The Novation Ceramic AHS is indicated for use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia and traumatic arthritis. Novation Ceramic AHS Acetabular Shells are intended for cementless, press-fit fixation. 1

4 Use of the Novation Ceramic AHS is contraindicated in the following situations: Active or latent infection in or around the hip joint; Acute or chronic systemic infections; Skeletally immature patients; Neurological or muscular conditions (e.g., prior paralysis, fusion and/or inadequate abductor strength) that could result in instability or overloading of the hip joint; Poor skin coverage around hip joint; Patients with inadequate bone stock to allow proper insertion and fixation of the prosthesis; Metabolic bone disease and osteoporosis; Patients with known allergies to the implant materials; and Obese patients where obesity is defined as a Body Mass Index (BMI) greater than 35. The description of this operative technique for implantation of the Novation Ceramic AHS should be used in conjunction with proper orthopaedic surgery training. There are certain surgical guidelines that are specific to Novation Ceramic AHS and must be followed as directed in this technique in order to obtain the intended clinical results. The Warnings and Precautions (see package insert at end of this technique for complete list) recommended were designed to reduce the potential incidence of chipping, malpositioning, breakage and improper fixation associated with ceramicon-ceramic acetabular systems. CAUTION Use caution when handling ceramic components during assembly because of the brittle nature of ceramic material. When using a ceramic-on-ceramic articulating hip system, it is important not to disassemble/reassemble the ceramic components from their mating counterparts (ceramic femoral head and femoral stem, ceramic acetabular liner and metal acetabular shell). Doing so may damage these mating surfaces and lead to early failure. Do not implant this hip system in patients undergoing revision of previously unsuccessful femoral head replacement, cup arthroplasty, or other indications (e.g. inflammatory hip joint disease) because the safety and effectiveness of these devices for indications other than primary, non-inflammatory degenerative joint disease have not been established. Note: Prior to use of the Novation Ceramic AHS, the surgeon should refer to the package insert located at the end of this technique for complete warnings, precautions, indications, contraindications and adverse effects. Additional copies of the package insert are available from Exactech. 2

5 PRE-OPERATIVE PLANNING The surgeon is to ensure that no biological, biomechanical, biomaterial or other factors exist that might adversely affect the surgery and/or post-operative period. Bone quality should be considered to ensure that the prosthesis does not subside, tilt, or migrate; fracture of host bone should also be considered. Such events could result in adverse outcomes. The expected useful life of the device may be compromised in very large or overweight individuals and in individuals who have a physically active lifestyle. The largest size components that will achieve the desired anatomic and functional characteristics for the patient are recommended. Improper selection, placement, positioning and fixation of the implant components may result in unusual stress conditions and subsequent early failure/fracture of the components and/or host bone. Estimate the acetabular component size by placing the overlay templates on the film selecting a size that matches the contour of the patient s acetabulum without the removal of excessive subchondral bone. To ensure a congruent fit, the medial position of the acetabular template should be lateral to the lateral aspect of the teardrop with the inferior part of the cup level with the obturator foramen and the superior position marked by the true superior edge of the acetabulum. Templating should be done on the affected side, but the contralateral side may also be templated to confirm size. Mark the center of rotation and the expected acetabular component size on the radiograph of the femur. Carefully examine each component and its packaging for any signs of damage that may have occurred during shipping or handling (e.g. if dropped on the floor or if scratched by an instrument). Do not implant components if the packaging is damaged or the implant shows signs of damage. Use of damaged components may lead to premature failure of the device. Due to the brittle nature of the material, ceramic components are particularly susceptible to premature failure when scratched, cracked or otherwise damaged. Examine instruments and confirm functionality prior to use. Instruments that have been subjected to overuse or misuse conditions are susceptible to failure or may damage implants and should not be used EXACTECH GROUP 1 BROWN 48mm O.D. / 28mm I.D. GROUP 1 BROWN 50mm O.D. / 28mm I.D. templating Accurate pre-operative planning and acetabular templating are essential for obtaining a successful outcome. Estimate the acetabular size utilizing the Novation Ceramic AHS hip templates along with the appropriate femoral templates in the A/P view. The desired magnification for all imaging should be 120 percent, which corresponds to the templates provided for the Novation Ceramic AHS system. For the A/P view, the patient is placed supine with both extremities placed in 15 degrees of internal rotation to position the head and neck parallel to the coronal plane. The radiograph should be centered on the symphysis pubis and should clearly show the acetabular construct with the endosteal and periosteal contours of the femoral head, neck and proximal femur. GROUP 2 BLUE 52mm O.D. / 32mm I.D. Ceramic AHS Groups 1 and 2: 48, 50, 52mm Note: Dimensions reflect reamed size. Actual implant will provide 1.0mm of press fit. 120% Magnification Catalog No Ceramic Acetabular Template Set 1106 Please note that the pre-operative template is to be used as a guide only final size and position of the component should be determined intra-operatively Rev- Ceramic AHS 48,50,52mm 3

6 OPERATIVE TECHNIQUE OVERVIEW 1 2 Acetabular Reaming Shell Trial Placement 5 Screw Preparation by Flexible Drill Shaft and 45-Degree Fixed Angle Drill Shaft (Optional) 8 Trial Reduction 9 Ceramic Liner Assembly 4

7 3 4 Assembly of Ceramic Shell Shell Impaction 6 Measurement of Pilot Hole for Screw Selection (Optional) 7 Screw Placement (Optional) 10 Liner Insertion 11 Final Impaction 5

8 DETAILED OPERATIVE TECHNIQUE The entire prosthesis size range should be available at the time of the surgery. Selecting the correct type of prosthesis with the correct size for each specific application is essential to the success of the procedure. Approach and Exposure This operative technique assumes that the patient has been positioned in the lateral decubitus position. However, the Novation Ceramic AHS instrumentation is compatible with any standard approach necessary to gain exposure of the acetabulum. Acetabular Reaming Step 1: Assemble the acetabular Reamer Handle into the power source. Assemble a hemispherical acetabular reamer 4 to 6mm smaller than the size templated onto the Reamer Handle. Step 2: Circumferential exposure of the acetabulum is essential prior to beginning reaming. Osteophytes and peripheral soft tissue should be removed to gain assessment of the acetabular rim. Step 3: Initial reaming may be directed more medially, though subsequent reaming should be done in 45 degrees of abduction and 20 degrees of anteversion (Figure 1). Step 4: Continue reaming incrementally until the articular cartilage has been removed and bleeding bone has been exposed along the superior dome anterior and posterior walls. Care should be taken to avoid excessive acetabular thinning and to maintain as much subchondral bone as possible. Figure 1 Acetabular Reaming Note: Novation Ceramic AHS Acetabular Shells are available in even millimeter increments (see System Specifications on page 12 for complete offerings). Acetabular Trialing Step 1: Assemble the appropriate Acetabular Shell Trial onto the Acetabular Shell Impactor and insert into the socket (Figure 2). Trialing of the shell will determine reaming accuracy as well as judging final placement of the acetabular implant relative to the peripheral rim. Step 2: Check quality of fit and bone apposition and remove the Shell Trial. The Novation Ceramic AHS Acetabular Shell is oversized a total of 1mm as compared to the Acetabular Reamer and Shell Trial in order to provide an appropriately secure interference fit. Under-reaming is usually not necessary where adequate bone stock is present. Figure 2 Shell Trial Placement 6

9 Acetabular Shell Implantation Caution: Always ensure proper alignment and seating of provisional implants prior to implantation of the definitive prosthesis. Improperly positioned components may not be immediately obvious and may result in device failure. Step 1: Assemble the appropriately sized Shell onto the Shell Impactor by squeezing the handle of the Shell Impactor and inserting the tip into the recessed area at the apex of the Acetabular Shell. Release the handle to engage the Shell Impactor (Figure 3). Note the position of the screw holes relative to the lever of the Shell Impactor. Figure 3 Assembly of Ceramic Shell Step 2: Introduce the Acetabular Shell into the reamed acetabulum and impact it into place. Correct alignment is typically 45 degrees of inclination and 20 degrees of anteversion as indicated by the Shell Impactor Alignment Guide (Figure 4). Seating of the Acetabular Shell at this position is recommended to ensure proper positioning and to decrease the potential for dislocation and impingement. Stability of the bone-implant interface should be checked by applying moderate force to several areas on the rim of the prosthesis. Care must be used to avoid scratching the taper region of the interior of the implant. The acetabular implant should be firmly fixed within the acetabulum, with no gaps between the shell and the acetabulum. If the Acetabular Shell rotates within the acetabulum, a larger Acetabular Shell must be selected and the bone preparation process should be repeated by reaming to a larger size. Important: The position of the Acetabular Shell is crucial in the use of the Novation Ceramic AHS in order to reduce the incidence of impingement. If the surgeon desires a change in either the anteversion or inclination, an impactor or punch must not be used against the taper region of the titanium shell. This may damage the taper and cause the connection to malfunction. Avoid contacting the tapered flange with other instrumentation. If the tapered flange is scratched or damaged, the damaged implant should be removed and replaced with a new prosthesis. Figure 4 Shell Impaction 7

10 Step 3: If screw fixation is necessary in order to gain additional fixation, 6.5mm Bone Screws may be used. Select either a 3.2mm or 4.5mm Drill Bit and insert it into the Flexible Drill Shaft or the 45-Degree Fixed Angle Drill Shaft (Figures 5 and 6). Caution: Due to intrapelvic vascularity, screw placement in the medial aspect of the acetabulum must be carefully considered. Step 4: Drill to the appropriate depth pilot hole using the Adjustable Drill Guide for each screw placed. Be certain that the Adjustable Drill Guide is fully seated in the screw hole before drilling. The acetabular shell holes provide +/- 11 degrees of screw angulation for proper seating of the screw. Step 5: Determine screw length by inserting the Flexible Depth Gauge and sliding the barrel down into the screw hole (Figure 7). Step 6: Remove the Drill Guide and determine the screw length by reviewing the depth indicator on the shaft of the Flexible Depth Gauge. Using the 3.5mm Universal Screwdriver, insert the 6.5mm Bone Screw taking care to fully seat the screw (Figure 8). Failure to fully seat the screw could result in impingement with the locking mechanism of the ceramic acetabular liner. If extremely hard bone is encountered, Bone Taps with a bayonet connection are provided to aid in easier screw fixation. Caution: Only Exactech 6.5mm Bone Screws should be used with Novation Ceramic AHS implants. The use of other manufacturer s screws may result in improper seating of the ceramic liner. Figures 5 and 6 Screw Preparation by Flexible Drill Shaft and 45-Degree Fixed Angle Drill Shaft, respectively Figure 7 Measurement of Pilot Hole for Screw Selection Figure 8 Screw Placement 8

11 Table 1 Shell/Liner Groupings Acetabular Shell OD Group # Liner ID 48 50mm 1 (Brown) 28mm 52mm 2 (Blue) 32mm 54 56mm 3 (Gray) 36mm 58 62mm 4 (Purple) 36mm 64 68mm 5 (Green) 36mm Ceramic Liner Trialing Step 1: Use of an acetabular Liner Trial is recommended prior to insertion of the definitive ceramic liner into the Acetabular Shell. Select the appropriately sized Liner Trial according to the Acetabular Shell inserted (Table 1). Step 2: Ensure that the inner taper of the Acetabular Shell is clear from soft tissue and debris before placing the Liner Trial. Clean and dry locking surfaces to ensure proper seating and assembly. Step 3: Place the Liner Trial into the Acetabular Shell. The Liner Trial is correctly aligned if the face of the liner and the Acetabular Shell are approximately parallel. The Liner Trial should remain in place until after trial reductions have been performed (Figure 9). Figure 9 Trial Reduction 9

12 Ceramic Liner Insertion Step 1: Remove the Liner Trial using the Novation Liner Trial Removal T-Handle. Place the T-Handle into the central slot of the Liner Trial, rotate approximately 90 degrees and then pull on the T-Handle to remove the Liner Trial. Ensure that the internal taper of the Acetabular Shell is clear from soft tissue and debris. The taper region of the ceramic acetabular liner should also be dry before insertion into the Acetabular Shell. Care should be taken not to scratch the taper surface of the ceramic liner or the inner taper of the metal shell. Any prostheses so damaged must not be used. Step 2: Based on the acetabular shell grouping, select the appropriately sized Liner Inserter and assemble to the Liner Driver Handle. Next, assemble the appropriate diameter Novation Liner Driver Head to the Liner Driver Handle. Select the appropriately sized Novation Ceramic AHS Liner and attach to the Ceramic Liner Inserter as shown in Figure 10. Step 3: Introduce the construct into the wound such that the Liner Inserter rests on the rim of the Acetabular Shell (Figure 11). Prior to impacting, confirm that all three prongs of the Liner Inserter are resting on the Acetabular Shell surface. With a mallet, strike the driving platform of the Liner Driver with one sharp blow (Figure 12). Repeated impaction of the Ceramic Liner in the Ceramic Shell when the initial attempt at seating the Liner is unsuccessful is not recommended and may lead to early failure. If the Ceramic Liner and Acetabular Shell are not fully seated or are aligned incorrectly after final impaction, it will be necessary to revise the metal Acetabular Shell and Ceramic Liner with new components. Figure 10 Ceramic Liner Assembly Figure 11 Liner Insertion Note: Use extreme caution in handling and storing the implant components. Damage to components may induce internal stresses that are not obvious and may lead to premature failure of the components. Examine the Ceramic Liner once implanted to make sure the liner is not chipped or damaged. If components exhibit damage such as chipping, cracking, etc., the component should be discarded. Figure 12 Final Impaction 10

13 Ceramic Liner INSERTION (ALTERNATIVE METHOD) Step 1: Remove the Liner Trial using the Liner Trial Removal T-Handle. Place the T-Handle into the central slot of the Liner Trial, rotate approximately 90 degrees and then pull on the T-Handle to remove the Liner Trial. Ensure that the internal taper of the Acetabular Shell is clear from soft tissue and debris. The taper region of the Ceramic Acetabular Liner should also be dry before insertion into the Acetabular Shell. Care should be taken not to scratch the taper surface of the Ceramic Liner or the inner taper of the metal Acetabular Shell. Any prostheses so damaged must not be used. Figure 13 Liner Insertion (Alternative Method) Figure 14 Final Impaction (Alternative Method) Step 2: Seat the appropriately sized Novation Ceramic AHS Acetabular Liner gently by hand into the Acetabular Shell taking care to ensure that the face of the Ceramic Liner is flush with the face of the Acetabular Shell (Figure 13). Prior to impacting, confirm that proper seating of the Ceramic Liner has occurred by palpating the shell/liner assembly. It is critical that the Ceramic Liner is stable within the Acetabular Shell prior to impacting with the ceramic liner driver instrument (Liner Driver Handle and Novation Liner Driver Head combined). The Ceramic Liner should be removed without impaction if the Ceramic Liner becomes misaligned within the Acetabular Shell. Step 3: Assemble the appropriate diameter Novation Liner Driver Head on the end of the Liner Driver Handle. With a mallet, strike the driving platform of the Liner Driver with one sharp blow (Figure 14). Repeated impaction of the Ceramic Liner in the Acetabular Shell when the initial attempt at seating the Ceramic Liner is unsuccessful is not recommended and may lead to early failure. The edge of the Ceramic Liner should sit completely flush with the edge of the Acetabular Shell prior to applying impaction force to the Ceramic Liner. If the Ceramic Liner and Acetabular Shell are not fully seated or are aligned incorrectly after final impaction, it will be necessary to revise the metal Acetabular Shell and Ceramic Liner with new components. 11

14 Ceramic Liner Removal (If Needed) Assemble the appropriately sized Ceramic Liner Removal Tool to the Liner Driver Handle. Align the tabs on the Ceramic Liner Removal Tool with the dimples on the shell face (Figure 15). Apply a mallet blow to the Ceramic Liner Removal Tool and inspect the Ceramic Liner for disengagement. Repeat if necessary until the liner is removed. Caution: If the ceramic liner is removed, the metal shell component cannot be reused with a ceramic component. The metal acetabular shell would then have to be removed, and a new shell inserted, since the shell can only have a ceramic liner inserted once because of deformation of the interior of the shell by liner impaction. See Femoral Stem/ Femoral Head Preparation note should the ceramic head need to be removed. Femoral Stem/Femoral Head Preparation Note: This section is abbreviated For complete information on femoral stem preparation, refer to the operative techniques for Exactech s compatible 12/14 taper femoral stem systems. Begin preparing the proximal femur by resecting the femoral head. Once the femoral head has been resected, the proximal femur must be opened using a box osteotome and round osteotome or starter reamer to prepare the canal for subsequent broaching. Broaching is performed to contour the stem envelope using progressive broach sizes beginning with a smaller broach than the templated prosthesis. Once the maximum broach size is in place, perform a trial reduction to assess joint stability. Remove the broach and insert the appropriate implant. Another trial reduction may be performed with the final femoral stem and trial femoral head. After completion of head length selection determined during the final trial reduction, select the appropriately sized Exactech alumina femoral head. Ensure that the trunnion of the femoral stem is free of debris and dry before placing the femoral head on the stem. Only use the femoral head impactor supplied with the Exactech femoral stem system to impact the alumina femoral head. Ensure that the outer diameter of the femoral head matches the inner diameter of the acetabular liner. Sizing mismatch will result in premature implant failure. Figure 15 Ceramic Liner Removal 12

15 Caution: Only the Exactech 12/14 taper femoral stems listed in the back of this technique can be used with Exactech alumina femoral heads and the Novation Ceramic AHS acetabular system. Do not use a metal or zirconia head with the Novation Ceramic AHS because this may accelerate bearing wear and lead to early failure of the device. Once the femoral stem taper has been assembled to a ceramic head, it should not be reassembled to another ceramic head. If the ceramic head is removed, a femoral stem with a new taper must be used or the implants must be converted to a CoCr on polyethylene articulation. Important: Prior to closure, the surgical site should be thoroughly cleansed of bone chips, extraneous bone cement (if used), ectopic bone, etc. Foreign particles may cause excessive wear. Foreign particles may also migrate to other parts of the body. Range of motion should be used to verify stability of the joint. Check for impingement and correct as appropriate. POST-OPERATIVE CARE Regular, long-term post-operative follow-up should be undertaken to detect early signs of component wear and loosening, and to consider the course of action to be taken if such events occur. Extreme care in patient handling (e.g., moving patient, placing on bedpans, changing clothes, etc.) immediately after surgery is necessary. A continuing periodic follow-up is recommended. Periodic X-rays should be taken to detect evidence of positional changes, loosening, bone loss and/or device fracture. All patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery. The patient should be warned against unassisted activity, particularly use of toilet facilities and other activities requiring excessive motion of the hip. Patients should be informed that their weight and activity level might affect the longevity of the implant. Patients should be advised to report any pain, decrease in range of motion, swelling, fever, or unusual sounds (e.g. clicking or squeaking) as this may indicate positional changes in the implant that could lead to premature failure. 13

16 SYSTEM SPECIFICATIONS The Novation Ceramic AHS acetabular shells incorporate a 1mm press fit into the sizing of the implants. An example of the amount of press fit is shown in the following illustration. COMPATIBLE EXACTECH 12/14 TAPER FEMORAL STEM PROSTHESES Only the following Exactech 12/14 femoral stem prostheses are compatible with Novation Ceramic AHS acetabular components: Reamer 50mm Femoral Prosthesis Novation 12/14 Tapered Press-Fit Plasma Femoral Stem (with and without HA coating) Operative Technique Novation 12/14 Splined Press-Fit Plasma Femoral Stem (with and without HA coating) Novation 12/14 Cemented Femoral Stem AcuMatch 12/14 Family Operative Technique (P-Series, C-Series, L-Series Femoral Stems) Please contact your Exactech Sales Representative, or Exactech Customer Service at , for the operative technique associated with the appropriate femoral stem prosthesis. Shell Trial 50mm Exactech implants are supplied sterile and intended for single use only. Ceramic AHS Shell 50mm (51mm true diameter due to porous coating) 14

17 Exactech Bone Screws Length (mm) MBA 6.5mm Bone Screws (Pointed Tip) 6.5mm Bone Screws (Full Radius Tip) * * * * * * * * Exactech 12/14 Alumina Femoral Heads (BIOLOX forte) Size (mm) Offset Exactech 12/14 Alumina Femoral Heads * * 65 N/A N/A 70 N/A * *Special order Novation Ceramic AHS Acetabular Shells and Liners Novation Ceramic AHS Plasma-Coated Acetabular Shells Novation Ceramic AHS Alumina Acetabular Liners (BIOLOX forte) Size Without HA With HA Group Liner ID G1 (Brown) 28mm G2 (Blue) 32mm G3 (Gray) 36mm G4 (Purple) 36mm G5 (Green) 36mm

18 INSTRUMENT LISTING Catalog Number Part Description Novation General Acetabular Instrument Case Drill Bit, 3.2 x 32mm Screw Holding Forceps Acetabular Shell Impactor, Straight Shell Impactor Alignment Guide * Acetabular Shell Impactor, Offset * Liner Driver Head Impactor Adapter Liner Driver Handle Novation Liner Trial Removal T-Handle Novation Liner Driver Head, 28mm Novation Liner Driver Head, 32mm Novation Liner Driver Head, 36mm T20 T22 T6159 Drill, Bayonet Connection, 4.5 x 20mm Drill, Bayonet Connection, 4.5 x 40mm Drill, Bayonet Connection, 3.2 x 20mm T6117 T6118 Screwdriver, Bayonet Connection, 2.5mm Screwdriver, Bayonet Connection, 3.5mm T6119 T6158 Bone Tap, Bayonet Connection, 6.5mm Flexible Depth Gauge *Special order 16

19 T6160 Flexible Drill Shaft, Bayonet Connection T6161 Universal Screwdriver, 3.5mm T6162 Ratcheting Driver Handle T6163 Adjustable Drill Guide T Degree Fixed Angle Drill Shaft, Bayonet Connection T6200 Drill Guide Sleeve, 3.2mm ID Novation Acetabular Reamer Instrument Case Acetabular Shell Trial, 48mm Acetabular Shell Trial, 50mm Acetabular Shell Trial, 52mm Acetabular Shell Trial, 54mm Acetabular Shell Trial, 56mm Acetabular Shell Trial, 58mm Acetabular Shell Trial, 60mm Acetabular Shell Trial, 62mm Acetabular Shell Trial, 64mm Acetabular Shell Trial, 66mm Acetabular Shell Trial, 68mm Reamer Handle, Straight Acetabular Reamer, 44mm Acetabular Reamer, 45mm Acetabular Reamer, 46mm Acetabular Reamer, 47mm Acetabular Reamer, 48mm Acetabular Reamer, 49mm Acetabular Reamer, 50mm Acetabular Reamer, 51mm Acetabular Reamer, 52mm Acetabular Reamer, 53mm Acetabular Reamer, 54mm Acetabular Reamer, 55mm 17

20 Catalog Number Part Description Acetabular Reamer, 56mm Acetabular Reamer, 57mm Acetabular Reamer, 58mm Acetabular Reamer, 59mm Acetabular Reamer, 60mm Acetabular Reamer, 61mm Acetabular Reamer, 62mm Acetabular Reamer, 63mm Acetabular Reamer, 64mm Acetabular Reamer, 65mm Acetabular Reamer, 66mm Acetabular Reamer, 67mm Acetabular Reamer, 68mm T6149* Chana Reamer Handle, Offset Novation Ceramic AHS Liner Instrument Case Ceramic Liner Removal Tool, 48mm Ceramic Liner Removal Tool, 50mm Ceramic Liner Removal Tool, 52mm Ceramic Liner Removal Tool, 54mm Ceramic Liner Removal Tool, 56mm Ceramic Liner Removal Tool, 58mm Ceramic Liner Removal Tool, 60mm Ceramic Liner Removal Tool, 62mm Ceramic Liner Removal Tool, 64mm Ceramic Liner Removal Tool, 66mm Ceramic Liner Removal Tool, 68mm Ceramic Liner Inserter, Group Ceramic Liner Inserter, Group Ceramic Liner Inserter, Group Ceramic Liner Inserter, Group Ceramic Liner Inserter, Group Liner Trial, 28mm, Group 1, 48/50mm Shell Liner Trial, 32mm, Group 2, 52mm Shell Liner Trial, 36mm, Group 3, 54/56mm Shell Liner Trial, 36mm, Group 4, 58/60mm Shell Liner Trial, 36mm, Group 5, 64/66/68mm Shell *Special order 18

21 PACKAGE INSERT Novation Ceramic AHS Exactech, 2320 NW 66th Court, Gainesville, Florida, Implants are supplied sterile. Surgical instruments are supplied non-sterile. DESCRIPTION The Exactech NOVATION Ceramic Articulation Hip System (AHS) is a ceramic-on-ceramic hip prosthesis system composed of the following components: Exactech 12/14 Alumina Femoral Head (BIOLOX forte) The alumina ceramic femoral heads have 12/14 tapers and are offered with outside diameters of 28mm, 32mm and 36mm in three neck lengths ( 3.5 mm, +0 mm, +3.5 mm). Exactech 12/14 Alumina Femoral Heads are compatible only with the Exactech femoral prostheses identified below. NOVATION Ceramic AHS Alumina Acetabular Liner (BIOLOX forte) The alumina ceramic acetabular liners are offered in seven sizes with internal diameters of 28mm, 32mm and 36mm. The seven sizes are designated as # (28/37G); # (32/41G); # (32/44G); # (32/48G); # (36/44G); # (36/48G); and # (36/52G). The 28mm ID liner fits shell sizes of 48-50mm OD. The 32mm ID liners fit shell sizes 52-62mm OD. The 36mm ID liners fit shell sizes 54-68mm OD. A male taper-fit connection allows assembly into the mating metal acetabular shell components. The NOVATION Ceramic AHS Liners are only compatible with NOVATION Ceramic AHS Shells and Exactech 12/14 Alumina Femoral Heads. NOVATION Ceramic AHS Plasma-Coated Acetabular Shell The metal shells feature a 3-hole cluster design, are hemispherical and are offered in 11 sizes with outside diameters ranging from 48 to 68mm in 2mm increments. The titanium alloy metal shells are plasma sprayed with a commercially pure titanium coating and are also available with and without a hydroxylapatite coating. The acetabular shells are designed for cementless, press-fit fixation. Exactech 6.5mm Bone Screws or Exactech MBA 6.5mm Bone Screws (optional) Exactech 12/14 Femoral Stems The NOVATION Ceramic AHS uses the following commercially available and compatible Exactech cobalt chromium alloy and titanium alloy 12/14 femoral stems: AcuMatch 12/14 P-Series Press-Fit Plasma Femoral Stem AcuMatch 12/14 L-Series Press-Fit Femoral Stem AcuMatch 12/14 C-Series Cemented Femoral Stem AcuMatch 12/14 L-Series Cemented Femoral Stem NOVATION 12/14 Tapered Press-Fit Plasma Femoral Stem NOVATION 12/14 Tapered Press-Fit Plasma/HA Femoral Stem NOVATION 12/14 Splined Press-Fit Plasma Femoral Stem NOVATION 12/14 Splined Press-Fit Plasma/HA Femoral Stem NOVATION 12/14 Cemented Femoral Stem Component Material Component Sizes Exactech 12/14 Alumina Femoral Heads NOVATION Ceramic AHS Alumina Liner NOVATION Ceramic AHS Plasma- Coated Acetabular Shell Exactech 6.5mm Bone Screw Exactech MBA 6.5mm Bone Screw (optional) BIOLOX forte Alumina Ceramic (Al 2 O 3 ) ASTM F603 and ISO 6474 BIOLOX forte Alumina Ceramic (Al 2 O 3 ) ASTM F603 and ISO 6474 Titanium Alloy (Ti6Al4V) ASTM F1472 Plasma Spray Coating Commercially Pure Titanium ASTM F1580 HA Coating (optional) Hydroxylapatite - raw material ASTM F1185 Titanium Alloy (Ti6Al4V) ASTM F136 Titanium Alloy (Ti6Al4V) ASTM F136 Outside Diameters: 28mm, 32mm, 36mm Head Lengths: Short (-3.5mm) Medium (+0mm) Long (+3.5mm) Inside Diameters: 28mm, 32mm, 36mm Outside Diameters: 48-68mm (2mm increments) Press-fit coating adds 1mm to nominal diameter. Shells are available with and without the HA coating. Diameter: 6.5mm Lengths: 15-80mm Diameter: 6.5mm Lengths: 15-80mm Use if supplemental fixation of the acetabular shell is required. 19

22 Component Material Component Sizes AcuMatch 12/14 P-Series Press-Fit Plasma Femoral Stem AcuMatch 12/14 L-Series Press-Fit Femoral Stem AcuMatch 12/14 C-Series Cemented Femoral Stem AcuMatch 12/14 L-Series Cemented Femoral Stem NOVATION 12/14 Tapered Press-Fit Plasma Femoral Stem NOVATION 12/14 Splined Press-Fit Plasma Femoral Stem NOVATION 12/14 Cemented Femoral Stem Titanium Alloy (Ti6Al4V) ASTM F1472 Plasma Spray Coating Commercially Pure Titanium ASTM F1580 Titanium Alloy (Ti6Al4V) ASTM F1472 Cobalt Chromium (Co28Cr6Mo) ASTM F799 Cobalt Chromium (Co28Cr6Mo) ASTM F799 Titanium Alloy (Ti6Al4V) ASTM F1472 Plasma Spray Coating Commercially Pure Titanium ASTM F1580 HA Coating (optional) Hydroxylapatite - raw material ASTM F1185 Titanium Alloy (Ti6Al4V) ASTM F1472 Plasma Spray Coating Commercially Pure Titanium ASTM F1580 HA Coating (optional) Hydroxylapatite - raw material ASTM F1185 Cobalt Chromium (Co28Cr6Mo) ASTM F799 Tapered stem with two neck offsets (Sizes 0-7) Tapered stem with one neck offset (Sizes 0-6) Tapered stem with two neck offsets (Sizes 1-6) Tapered stem with one neck offset (Sizes 1-5) Tapered stem with two neck offsets (Sizes 9-18) Plasma stems are available with and without the HA coating. Splined stem with two neck offsets (Sizes 9-18) Plasma stems are available with and without the HA coating. Tapered stem with two neck offsets (Sizes 9,11,13,15,17) Exactech implants are supplied sterile and are intended for single use only. A complete instrumentation and trial system is available to assist in the implantation of each component. For a more detailed description of the implants, instruments and their utilization, please refer to the surgical technique, or contact your Exactech sales representative. INDICATIONS FOR USE The NOVATION Ceramic AHS is indicated for use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis. CONTRAINDICATIONS Active or latent infection in or around the hip joint; Acute or chronic systemic infections; Skeletally immature patients; Neurological or muscular conditions (e.g., prior paralysis, fusion and/or inadequate abductor strength) that could result in instability or overloading of the hip joint; Poor skin coverage around hip joint; Patients with inadequate bone stock to allow proper insertion and fixation of the prosthesis; Metabolic bone disease and osteoporosis; Use in patients with known allergies to the implant materials; and Obese patients where obesity is defined as a Body Mass Index (BMI) greater than 35. WARNINGS AND PRECAUTIONS Certain insertion techniques may be different from those known for conventional hip systems. The Warnings and Precautions below are recommended and were designed to reduce the potential incidence of chipping, malpositioning, breakage and improper fixation associated with ceramic-on-ceramic acetabular systems. Only qualified surgeons knowledgeable in the anatomy, biomechanics, and reconstructive surgery should utilize these devices. The surgeon should be fully knowledgeable of the implants, implant compatibility, instruments and surgical procedure prior to performing surgery. The surgeon should review all aspects of the Exactech NOVATION Ceramic AHS surgical technique and other training materials supplied by Exactech prior to use. The surgeon should be trained according to the proper use of the system instrumentation. For more information, contact your Exactech sales representative. Warnings Do not allow damage to the polished bearing surfaces or taper locking surfaces. Any alteration, damage, contour or bend to these surfaces will reduce the fatigue strength of the prostheses and may result in failure under load. Any prostheses so damaged must not be used. Seat the acetabular shell at 45 inclination with 20 anteversion to ensure proper positioning and to decrease the potential for dislocation and impingement. Always ensure proper alignment and seating of provisional implants prior to implantation of the definitive prosthesis. Improperly positioned components may not be immediately obvious and may result in device failure. Ensure correct selection of the head neck length, cup and stem. Increased neck length and varus positioning will increase stresses that must be borne by the stem. Do not disassemble and reassemble the ceramic liner to the acetabular shell as the taper joint may become deformed during this process. Damage to the shell taper may affect the locking mechanism between the liner and shell and increase the risk of ceramic liner fracture. Replace both the ceramic liner and the metal acetabular shell if the ceramic liner is chipped, cracked, or otherwise damaged during shell/liner assembly. Once the acetabular shell taper has been assembled to a ceramic liner, it should not be reassembled to another ceramic liner. A deformed metal taper could significantly affect the locking mechanism between the new liner and shell and increase the risk of ceramic liner fracture. Do not scratch or dent the rim or internal taper of the acetabular shells. If the rim or taper joint is damaged during implantation, the acetabular shell should be replaced, as the deformation of the shell taper may affect the locking mechanism between the liner and shell and increase the risk of ceramic liner fracture. Only use NOVATION BIOLOX forte Ceramic AHS Acetabular Liners with Exactech 12/14 BIOLOX forte Alumina Femoral Heads. Ensure that the outer diameter of the femoral head matches the inner diameter of the acetabular liner. Use of other components (e.g. metal femoral heads, zirconia ceramic femoral heads, another manufacturer s alumina heads) may accelerate bearing wear and lead to early failure of the system. Only use NOVATION Ceramic AHS Acetabular Shells with NOVATION BIOLOX forte Ceramic AHS Acetabular Liners. Use of other manufacturer acetabular shell components may result in disassembly and/or fracture of the liner and lead to early failure of the system. Only use the compatible Exactech 12/14 Femoral Stem components identified in the Description section with the NOVATION Ceramic AHS femoral head, liner and acetabular components. Use of other femoral stem components (e.g. Exactech femoral stems that do not have a 12/14 taper, another manufacturer s femoral stems) may result in fracture or damage to the femoral head and/or liner components and lead to early failure of the system. Do not implant in pregnant patients as the extra weight and exposure to radiation may be harmful to the implant and fetus. Do not implant in obese patients because overloading the component may lead to fracture or loss of fixation. Implants are for single use only. Do not reuse an implant. Any implant, once used, should be discarded even though it may appear undamaged. Do not re-sterilize implants. In particular, heat sterilization of ceramic components followed by sudden cooling may cause undetectable damage and lead to device failure. Failure to follow these recommendations will result in increased probability of poor function, loosening, wear, fracture or premature failure. Do not implant this hip system in patients undergoing revision of previously unsuccessful femoral head replacement, cup arthroplasty, or other indications (e.g. inflammatory hip joint disease) because the safety and effectiveness of these devices for indications other than primary non-inflammatory degenerative joint disease have not been established. 20

23 Precautions Pre-operative The patient should be informed of all potential risks and adverse effects contained in this insert. The patient should be warned that the implants can break or become damaged as a result of strenuous activity or trauma, including extreme activity or heavy labor for occupation. Ensure that no biological, biomechanical, biomaterial or other factors exist which might adversely affect the surgery and/or post-operative period. Bone quality should be considered to ensure that the prosthesis does not subside, tilt, or migrate; fracture of host bone should also be considered. Such events could result in adverse outcome. The expected useful life of the device may be compromised in very large or overweight individuals and in individuals who have a physically active lifestyle. The largest size components that will achieve the desired anatomic and functional characteristics for the patient are recommended. Improper selection, placement, positioning and fixation of the implant components may result in unusual stress conditions and subsequent early failure/fracture of the components and/or host bone. Carefully examine each component and its packaging for any signs of damage that may have occurred during shipping or handling (e.g. if dropped on the floor or if scratched by an instrument). Do not implant components if the packaging is damaged or if the implant shows signs of damage. Use of damaged components may lead to premature failure of the device. Due to the brittle nature of the material, ceramic components are particularly susceptible to premature failure when scratched, cracked or otherwise damaged. Examine instruments and confirm functionality prior to use. Instruments that have been subjected to overuse or misuse conditions are susceptible to failure or may damage implants and should not used. Intra-operative The entire prosthesis size range should be available at the time of the surgery; selecting the correct type of prosthesis with the correct size for each specific application is essential to the success of the procedure. Use caution when handling ceramic components during assembly because of the brittle nature of ceramic material. Clean and dry surfaces that lock to ensure proper seating and assembly. Ensure that prior to liner insertion, soft tissue does not interfere with the shell/liner interface. Modular components should be assembled securely to prevent disassociation. When using cement for fixation of the mating femoral components, the surgeon should ensure complete cement support on all parts of the prosthesis embedded in bone cement. When assembling the acetabular components, first place the ceramic liner into the metal shell by hand. Prior to impacting, confirm that proper seating of the ceramic liner has occurred by palpating the shell/liner assembly. It is critical that the ceramic liner is stable within the shell prior to impacting with the ceramic liner driver instrument. Impaction should not occur and the ceramic liner should be removed if it becomes mal-aligned within the shell. Repeated impaction of the liner in the shell when the initial attempt at seating the liner is unsuccessful is not recommended and may lead to early failure. If the ceramic liner and shell are not fully seated or are aligned incorrectly after final impaction, it will be necessary to revise the shell and liner with new components. After the liner has been inserted, the liner should be examined in situ for evidence of chipping (visible evidence of ceramic fracture). If chipped, scratched, or otherwise damaged during the implant procedure, replace both the ceramic liner and the acetabular shell. Once the femoral stem taper has been assembled to a ceramic head, it should not be reassembled to another ceramic head. If the ceramic head is chipped, cracked, or otherwise damaged during head/stem assembly, replace both the ceramic head and the femoral stem. Do not use a metal or zirconia head with the NOVATION Ceramic Articulation Hip System because this may accelerate bearing wear and lead to early failure of the device. In order to prevent sepsis, the physician is advised to comply with the following recommendations: Consistent use of prophylactic antibiotics; Utilize a laminar flow clean air system; Assure that all operating room personnel, including observers, are properly attired; Protect instruments from airborne contamination; Use impermeable draping. Use only Exactech 6.5mm Bone Screws or Exactech MBA 6.5mm Bone Screws if adjunctive fixation of the acetabular shell is desired. Pre-drill screw holes using either a 4.5mm or 3.2mm drill bit to facilitate screw installation. Ensure proper selection of the bone screw length and proper screw placement to avoid damage to underlying soft tissue structures. Perforation of the pelvic wall with screws that are too long can result in internal bleeding and possible damage to vital organs. Do not place a screw in the center apical hole of the acetabular shell. Completely seat bone screws to allow proper assembly of the ceramic liner to the metal shell. Prior to closure, the surgical site should be thoroughly cleansed of bone chips, extraneous bone cement (if used), ectopic bone, etc. Foreign particles may cause excessive wear. Foreign particles may also migrate to other parts of the body. Range of motion should be used to verify stability of the joint, check for impingement and corrected as appropriate. Post-operative Post-operative counseling and care is important. It is recommended that regular, long-term post-operative follow-up be undertaken to detect early signs of component wear and loosening, and to consider the course of action to be taken if such events occur. A suitable rehabilitation program should be designed and implemented. Extreme care in patient handling (e.g., moving patient, placing on bedpans, changing clothes, etc.) immediately after surgery is necessary. Adequate support should be provided to the operative leg when moving the patient to avoid placing excessive load on the operative leg. Excessive activity and trauma affecting joint replacements have been associated with premature failure. A continuing periodic follow-up is recommended. Periodic X-rays should be taken to detect evidence of positional changes, loosening, bone loss and/or device fracture. In such cases, patients should be closely monitored and the benefits of revision surgery should be considered in order to avoid further deterioration. All patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery. The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses, and follow the written instructions of the physician with respect to follow-up care and treatment. The patient should be warned against unassisted activity, particularly use of toilet facilities and other activities requiring excessive motion of the hip. Patients should be informed that their weight and activity level may affect the longevity of the implant. Patients should be advised to report any pain, decrease in range of motion, swelling, fever, or unusual sounds (e.g. clicking or squeaking) as this may indicate positional changes in the implant that could lead to premature failure. Adverse Effects The following adverse effects may be associated with the use of this device. Although some effects are not directly attributable to the device itself, the surgeon should be aware of these potential complications and be ready to treat the patient accordingly. Failure of the prostheses due to any cause may result in the need for additional surgery. List of Potential Adverse Events Associated with Any Total Hip Arthroplasty Excessive wear of the implant components secondary to impingement of components or damage of articular surfaces. Osteolysis Fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision. Possible detachment of the coating(s) on the femoral stem or acetabular shell components, potentially leading to increased debris particles. Unintended bone fractures, including femoral or acetabular perforation while seating the device. Metal sensitivity reactions or other allergic/histological reactions to implant materials. Superficial or deep infection. Delayed wound healing. Vascular damage resulting in blood loss and/or hematoma, potentially requiring transfusion. Neurologic injury or neuropathy resulting in transient or permanent weakness, pain, and/or numbness. Undesirable leg lengthening or shortening. Periarticular calcification or ossification, with or without impediment to joint mobility. Cardiovascular disorders including venous thrombosis, pulmonary embolism, or myocardial infarction. Gastrointestinal complications. Genitourinary complications. Aggravation of other joint or back conditions due to positioning during surgery or neurological injury. Traumatic arthrosis of the hip from intra-operative positioning of the extremity. Decreased range of motion. Intractable pain. Death. 21