REFLECTION I & V POROUS-COATED ACETABULAR COMPONENT SURGICAL TECHNIQUE

Transcription

1 S M I T H & N E P H E W REFLECTION I & V POROUS-COATED ACETABULAR COMPONENT SURGICAL TECHNIQUE

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3 REFLECTION I & V POROUS-COATED ACETABULAR COMPONENT designed in conjunction with Ramon B. Gustilo, M.D. Richard F. Kyle, M.D. Nota Bene: This technique description herein is made available to the healthcare professional to illustrate the authors suggested treatment for the uncomplicated procedure. In the final analysis, the preferred treatment is that which addresses the needs of the patient.

4 I N T R O D U C T I O N The Reflection Acetabular System has incorporated several design features to address the problem of small particle polyethylene debris generation. To maximize stability of the liner in the shell, the MicroStable liner locking mechanism combines the axial and rotational lock in one noninvasive mechanism. To further reduce polyethylene debris, the inner shell surface is polished to a mirror smooth finish. This patented, highly polished inner surface, combined with the MicroStable liner locking mechanism minimize polyethylene debris. Reflection liners are now sterilized by a nondegrading method to eliminate damage associated with gamma sterilization. Another enhancing design feature is liner/ shell congruency. By maximizing the congruity between cup and liner, a better distribution of forces lowers the amount of contact stresses in the polyethylene liner which results in lower wear rates. To assure a good fit between liner and shell, a postsintering machining process ensures precise tolerances. For added stability, Reflection V incorporates ExtrusionLock modular pegs for stable fixation of the shell to the acetabulum. These pegs lock into the shell, further reducing the likelihood of generating poly or metal debris. The Reflection Acetabular System is available in several shell configurations. This technique describes the Reflection I and V shells. Reflection I has a threaded apex hole for cup insertion and visualization of the acetabulum. Reflection I is available in outside diameters, mm in 2 mm increments. Reflection I does not offer any type of adjunctive fixation options. Reflection V has five screw/peg holes in sizes mm. Reflection V 44 mm shell diameter has three holes for adjunctive fixation. Hole covers are available for shell closure. A threaded hole cover can be threaded into the apex hole of the Reflection I or V shell. Tapered hole covers are available to close the screw/peg holes on Reflection V. The Reflection MicroStable liner locking mechanism, highly polished inner surface, and improved cup and liner congruity, provide a better way to reduce polyethylene debris. 2

5 P R E O P E R A T I V E P L A N N I N G Preoperative templating is essential to the precise reconstruction of the hip joint. Suggested preoperative X-rays include an A-P of the pelvis and hips, a 14" x 17" A-P view of the affected hip and femur, and a lateral view of the affected hip. The acetabular component may be templated using the contralateral normal hip, if available, or templated directly on the affected hip. The acetabular component should congruently fit the subchondral bone and the medial aspect of the acetabulum as indicated by the teardrop. Mark the center of rotation of the acetabular component through the template for subsequent reference. A C E T A B U L A R E X P O S U R E A N D R E A M I N G Figure 1 Complete exposure of the acetabulum is necessary to ensure a satisfactory surgical result. Resect the acetabular labrum circumferentially in order to define the landmarks of the bony acetabulum. Clean soft tissue or osteophytes from the acetabular fovea in order to define the limits of the medial wall. Surrounding soft tissues must be protected by retraction during the reaming process to avoid injury to critical structures. Restoration of normal anatomy is an important principle of reconstructive hip surgery. The acetabulum must be medialized to restore the normal center of the hip rotation as determined by preoperative templating. Ream the acetabulum concentrically in order to ensure an excellent fit between the acetabulum and the acetabular component (Figure 1). Do not reverse the reamer direction during the reaming process. Acetabular Reamer Dome Acetabular Reamer Handle 3

6 To avoid excessive medial reaming of the acetabulum, ream only until the last row of reamer fenestrations is just contained within the acetabulum as overmedialization could occur. Only Reflection (or hemispherical) reamers should be used for Reflection acetabular components. Direct the reamer along the same axis as that desired for the final position of the acetabular prosthesis. This is generally in a position of approximately 45 of abduction and 20 to 30 of forward flexion. Preserve subchondral bone to provide good support for the prosthesis. Clean the acetabulum of all remaining cartilage and soft tissue down to bleeding subchondral bone. The posterior and anterior walls (columns) of the acetabulum must be considered while reaming, since they are the limiting factor in determining the largest size prosthesis that can be accommodated. Frequently palpate these structures during the reaming process to determine the maximum reamer size that should be used. To assess the fit and stability of the prepared acetabulum, use the trial shell. Visualize through the slots in the trial to determine the trial/bone contact. Note the relationship of the trial to the surrounding bony landmarks; this will aid in determining the position for inserting the acetabular shell (Figure 2). Figure 2 Trial Shell Trial Shell Handle 4

7 Make sure the acetabular shell will be contained as completely as possible without exposing the porous coating. If the position is not correct, further ream the acetabulum as necessary. An intraoperative X-ray may help evaluate the position and remaining bone stock of the acetabulum. For press-fit of a porous-coated prosthesis, it is best to under-ream the acetabulum by 1 to 2 mm. The quality of bone stock should determine whether underreaming is appropriate. Subchondral bone should be preserved whenever possible. A C E T A B U L A R S H E L L I N S E R T I O N Figure 3 Select the appropriate acetabular implant. Attach the selected prosthesis to the cup positioner/impactor and insert it into the acetabulum. The positioner references 45 of abduction and 20 of forward flexion. Position the X-bar so that the vertical bar is perpendicular to the long axis of the body and the appropriate crossbar aligns with the long axis of the body (Figure 3). Firmly impact the inserter with a mallet. Assess the stability and contact of the prosthesis by pushing on the rim of the device with a femoral head pusher or a similar instrument. No motion should be apparent during the evaluation, indicating excellent press-fit of the prosthesis. X-Bar Cup Positioner/Impactor 5

8 U S E O F S C R E W S F O R A D J U N C T I V E F I X A T I O N The following sections on adjunctive fixation refer to Reflection V only. Adjunctive fixation is not available for Reflection I. Generally, cancellous screws will provide satisfactory adjunctive fixation. Four drill bits of progressively increasing length are available. CANCELLOUS SCREW OPTIONS Screw Length Drill Length Drill Cat. No. 15 mm 20 mm, 25 mm 30 mm, 35 mm 40 mm, 50 mm 15 mm 25 mm 35 mm 50 mm Figure 4 When positioning screw fixation holes, keep in mind that the best quality bone for fixation screw holes is in the superior, medial (weight bearing) region of the acetabulum. The ischium and pubis will provide less satisfactory engagement of screw threads. Take care, when positioning and drilling holes, to avoid penetration of the inner cortex of the pelvis, penetration of the sciatic notch, or damage to vital neurovascular structures. Do not place a screw in the center hole of the acetabular prosthesis. Placement of drills and screws in the anterior or medial portions of the prosthesis is associated with a high risk of potentially fatal vascular injury. To predrill each screw hole, first seat the screw drill guide fully through the correct hole in the acetabular shell (Figure 4). The drill guide will position the screw properly, avoiding impingement of the screw head against the shell. Drill each screw hole, taking care to not drill directly medially or directly anteriorly. When screws are to be placed in the direction of the sciatic notch, palpate the notch so that injury to the sciatic nerve can be avoided. Screw Drill Screw Drill Guide ADJUNCTIVE FIXATION AVAILABLE FOR REFLECTION V ONLY. 6

9 Figure 5 Before inserting the screws, use the depth gauge to verify the appropriate screw length(s) (Figure 5). This will help avoid penetration of the screws through the inner table of the pelvis. Use the screw holding forceps or the universal screwdriver to hold the screw. Flex the tip of the universal screwdriver in an upward position to hold the screw. Introduce the screw into the hole and screw it into place (Figure 6). Make sure the screw is fully seated within the screw hole so that it will not impinge on the acetabular shell liner. An inner diameter feeler gauge is provided to determine if the screw is fully seated (Figure 7). Reassess stability of the prosthesis by pushing on it and noting any motion. No motion should be observed. If instability is noted, consider inserting the next larger prosthesis or using cement fixation. Angled Depth Gauge Figure 6 Curved Screw Forceps Ratchet Screwdriver Handle Flexible Screwdriver Shaft Universal Screwdriver Shaft Figure 7 Feeler Gauge ADJUNCTIVE FIXATION AVAILABLE FOR REFLECTION V ONLY. 7

10 U S E O F P E G S F O R A D J U N C T I V E F I X A T I O N Modular taper lock pegs can also be used to assist in stabilization of the acetabular prosthesis. The modular taper lock peg is available in a 15 mm length with a blunt tip. A 15 mm drill bit and a peg drill guide are available for preparation of the peg holes. When positioning peg holes, keep in mind that the best quality bone for pegs is in the superior, medial (weight bearing) region of the acetabulum. The ischium and pubis will provide less satisfactory stability. Take care, when positioning and drilling peg holes, to avoid penetration of the sciatic notch, or damage to vital neurovascular structures. When using pegs, the selected holes must be predrilled with the 15 mm peg drill and peg drill guide. Drill each peg hole, taking care not to drill directly medially or directly anteriorly. Verify the depth of the drilled hole with the angled depth gauge. When pegs are placed in the direction of the sciatic notch, palpate the notch so that injury to the sciatic nerve can be avoided. Do not place a peg in the threaded center hole of the acetabular prosthesis. Before inserting the peg, inspect hole depth using depth gauge and use pulsatile lavage and suction to clean the peg holes. All bone debris must be cleaned from the peg holes to ensure proper taper lock between the peg and hole taper. Peg Drill Straight Peg Impactor Peg Drill Guide Angled Peg Impactor ADJUNCTIVE FIXATION AVAILABLE FOR REFLECTION V ONLY. 8

11 Figure 8 When inserting two or more pegs, insert all pegs into the shell by hand and then impact with the peg impactor and three moderate blows of a mallet (Figure 8). Inspect the inner surface of the shell for peg seating. An inner diameter feeler gauge is provided to determine if the peg is fully seated (Figure 9). If the peg is not flush with the inner diameter of the shell, impact the peg again. Reassess stability of the prosthesis by pushing the rim of the shell and noting any motion. No motion should be observed. If instability is noted, consider inserting the next larger prosthesis or using cement fixation. Peg Removal Technique To remove a threaded peg, thread a disposable peg removal pin into the peg by hand until it stops. Place the peg removal instrument over the head of the removal pin (Figure 10). Squeeze (close) the handles of the peg removal tool to remove the peg. Use a new peg removal pin for each peg. Figure 9 Peg Removal Pin Peg Removal Tool Figure 10 ADJUNCTIVE FIXATION AVAILABLE FOR REFLECTION V ONLY. 9

12 USE OF HOLE COVERS FOR CLOSURE Once the shell is stable, tapered and/or threaded hole covers can be used to close any unused holes. Before inserting the tapered or threaded hole cover, use pulsatile lavage and suction to clean the holes. All bone debris must be cleaned from the holes to ensure proper locking between the hole cover and the shell. Tapered Hole Covers Tapered hole covers can only be used with Reflection V in the holes designed to accommodate pegs or screws. Do not place a tapered hole cover in the threaded apex hole. Use the disposable taper hole cover inserter to place the cover in the hole (Figure 11). Push the tapered hole cover straight into the screw hole with the inserter, then lever the inserter out of the hole cover. After placing the tapered cover in the hole, position the peg impactor in the tapered hole cover dimple and impact with three moderate blows of a mallet. Inspect the inner surface of the shell for cover seating. An inner diameter feeler gauge is provided to determine if the cover is fully seated. If the tapered hole cover is not flush with the inner diameter of the shell, impact it again. Figure 11 Threaded Hole Covers Threaded hole covers can be used with the Reflection I and V shell in the center apex hole. Insert the threaded hole cover into the center hole using the Reflection screwdriver (Figure 12). Tighten the threaded hole cover until it stops. Remove the screwdriver and use the inner diameter feeler gauge to determine if the threaded hole cover is fully seated (Figure 13). If the threaded hole cover is not flush with the inner diameter of the shell, the screwdriver should be reinserted and the hole cover should be tightened further. Figure 12 Tapered Hole Cover Inserter Figure 13 10

13 A C E T A B U L A R L I N E R I N S E R T I O N With the acetabular shell firmly positioned, place the appropriate trial liner into the acetabular shell and perform a trial reduction. Insertion of the trial liner may help assess possible tissue impingement at the locking mechanism. (Alternatively, the permanent acetabular liner may be inserted at this time.) Femoral Head Size POLYETHYLENE THICKNESS A C E T A B U L A R C U P S I Z E mm mm NA mm NA NA mm NA NA NA Socket liners are available with internal diameters of 22 mm, 26 mm, 28 mm, and 32 mm, with or without 20 rim extensions. The surgeon should select a femoral head size to maximize polyethylene thickness, i.e., small femoral heads should be used for small acetabular prostheses. Position the extension to optimize the stability of the reconstruction (generally in the superior/ posterior position). Before inserting the acetabular shell liner, the rim and interior of the acetabular shell should be carefully cleaned of any remaining soft tissue or bone debris. Then insert the liner, keeping the extension (if used) in the same position determined during the trial reduction. During liner insertion, make sure soft tissue does not interfere with the shell/liner interface. For liner impaction, place the appropriate liner impactor head on the end of the cup positioner/impactor. Prior to impacting the liner, ensure the splines on the liner are aligned with the splines of the shell. Liner Impactor Head Cup Positioner/Impactor Trial Liner Liner Removal Tool 11

14 The Reflection MicroStable liner requires an impaction force between 120 and 200 pounds at room temperature. The required impaction force increases with the diameter of the shell. Chilling the liner reduces the impaction force required to seat the liner. To ease liner insertion, chill the liner in refrigerated or iced saline for a minimum of five minutes. Chilling the liner is recommended for all liners, especially liners 58 mm and larger. Impact the liner until it is fully seated in the shell (Figure 14). It is important to hold the impactor perpendicular to the face of the cup while impacting the liner. Inspect to make sure the liner is properly seated. If removal of the liner is necessary, place the end of the acetabular liner removal tool into the slot in the rim of the acetabular shell until it engages the liner and the liner disengages from the shell. If the liner has not been damaged, it may be reinserted one time only. Figure 14 12

15 A C E T A B U L A R Reflection I and Reflection V Shells and Liners C O M P O N E N T S Reflection I Reflection V Shell Shell O.D. Liner Liner I.D. Cat. No. Cat. No. (mm) Size (mm) B C 22, D 22, 26, D 22, 26, E 22, 26, 28, E 22, 26, 28, F 22, 26, 28, F 22, 26, 28, G 22, 26, 28, G 22, 26, 28, H 22, 26, 28, H 22, 26, 28, J 22, 26, 28, J 22, 26, 28, K 22, 26, 28, 32 CATALOG INFORMATION Reflection Acetabular Liners 0º Liner 20º Liner I.D. Liner Cat. No. Cat. No. (mm) Size B C D E F G H J K C D E F G H J K D E F G H J K E F G H J K 13

16 CATALOG INFORMATION Universal Acetabular Cancellous Screws 6.5 mm Cat. No. Length mm mm mm mm mm mm mm Reflection Acetabular Fixation Peg 15 mm Length Cat. No Reflection Hole Covers Cat. No. Description Tapered Threaded 14

17 A C E T A B U L A R T R I A L S Reflection Trial Acetabular Shells Cat. No. O.D. Cat. No. O.D mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm CATALOG INFORMATION Reflection Trial Acetabular Liners 0º 20º Liner Cat. No. Cat. No. I.D. Size mm B mm C mm D mm E mm F mm G mm H mm J mm K mm C mm D mm E mm F mm G mm H mm J mm K mm D mm E mm F mm G mm H mm J mm K mm E mm F mm G mm H mm J mm K 15

18 CATALOG INFORMATION A C E T A B U L A R C O M P O N E N T I N S T R U M E N T A T I O N Acetabular Reamer Handle 38 mm 70 mm Cat. No Acetabular Trial Liner Handle (Optional) Cat. No. Size mm mm mm mm Acetabular Reamer Domes Cat. No. Size Cat. No. Size mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm Acetabular Liner Extractor Cat. No Angled Depth Gauge Cat. No Acetabular Cup Screwdriver Ratchet Handle Cat. No Acetabular Cup Universal Screwdriver Shaft Cat. No Acetabular Cup Flexible Screwdriver Shaft Cat. No

19 R E F L E C T I O N I & V Tapered Hole Cover Inserter Cat. No Acetabular Screw Drills Cat. No. Length mm mm mm mm CATALOG INFORMATION Acetabular Screw Drill Guide Cat. No Acetabular Peg Drill Guide Cat. No Acetabular Straight Peg Impactor Cat. No Acetabular Angled Peg Impactor Cat. No Peg Drill 15 mm Length Cat. No Trial Handle Cat. No Acetabular Cup Positioner/Impactor Cat. No Reflection Curved Screw Forceps Cat. No. Bend º º 17

20 CATALOG INFORMATION T-Handle Hex Wrench Cat. No X-Bar Cat. No. MT-2201 Acetabular Cup I.D. Feeler Gauge Cat. No Acetabular Cup Liner Impactor Heads Cat. No. Size mm mm mm mm Peg Removal Tool Cat. No Peg Removal Pin Cat. No

21 A C E T A B U L A R Primary Instrument Tray Cat. No Trial Acetabular Liner Tray Cat. No T R A Y S CATALOG INFORMATION Trial Acetabular Liner Tray Insert Cat. No Trial Acetabular Shell Tray Cat. No Reamer Dome Tray 38 mm - 70 mm Cat. No

22 IMPORTANT MEDICAL INFORMATION Warnings and Precautions POROUS COATED TOTAL HIP SYSTEM IMPORTANT NOTE Total hip replacement arthroplasty has become a successful procedure in relieving pain and restoring motion in patients who are disabled from hip arthropathy. The goals of total hip replacement are to decrease pain, increase function, and increase mobility. To accomplish these goals, patients should be selected who: 1. have and are expected to maintain adequate bone support; 2. are anatomically able to accept the size prosthesis commensurate with their activity and load requirements; and 3. are able and willing to follow their physician s directions generally, and particularly with respect to no or minimal weight bearing postoperative care. Insert the largest stem feasible (especially in large patients). Patients should be cautioned against any heavy labor, active sports, or any activity which places heavy or abrupt loads on implanted prostheses. DESCRIPTION OF SYSTEM The Porous Coated Total Hip System consists of femoral components, proximal pads, taper sleeves, distal sleeves, acetabular shells and liners, fixation screws and pegs, and hole covers. The porous coated products promote biological ingrowth. All implantable devices are for single use. Materials Femoral components, proximal pads, taper sleeves, distal sleeves, acetabular shells, fixation screws and pegs, and hole covers are Titanium 6 Aluminum 4 Vandium Alloy (ISO 5832/3). The femoral components, proximal pads, porous coated distal sleeves, and acetabular shells have a coating of commercially pure (C.P.) titanium beads (ASTM F 67 and ISO 5832/2). Acetabular liners are manufactured from UHMWPE (ASTM F 684). The specific component material is provided on the outside carton labels of the components. Some of the alloys needed to produce orthopaedic implants contain some metallic components that may be carcinogenic in tissue cultures or intact organisms under very unique circumstances. Questions have been raised in the scientific literature as to whether or not these alloys may be carcinogenic in implant recipients. Studies conducted to evaluate this issue have not identified convincing evidence of such phenomenon, in spite of the millions of implants in use. Femoral Components Femoral components are available in a variety of sizes to provide a snug fit in the intramedullary canal. Femoral components are porous coated proximally for biological ingrowth. Modular stems also accept a porous coated distal sleeve for distal biological growth. Femoral components are available in either a small or large taper. The large tapers are machined to mate and lock with either 26, 28, or 32 mm metal or ceramic heads. The large taper femoral components may also be used with bipolar components or unipolar heads. The small tapers mate directly with a 22 mm metal head and with a taper sleeve which in turn mates with either 26, 28, or 32 mm metal or ceramic heads, bipolars, or unipolars. Taper Sleeves A taper sleeve is required to be impacted on the small taper femoral components prior to impacting femoral heads of 26, 28, or 32 mm. A taper sleeve is required to attach a unipolar head. Unipolar taper sleeves are available in both small and large tapers. Never place more than one taper sleeve on a femoral component. Femoral Heads Cobalt Chromium and Zirconium alloy heads and ceramic heads are available in a variety of diameters and neck lengths for proper anatomic and musculature fit. The following Zirconium Alloy Metal Heads and Zirconia Ceramic Heads are available for use with porous coated femoral components: Zirconium Zirconia Head Alloy Heads Ceramic Heads Diameter Neck Length mm Short 3 mm mm Standard 0 mm mm Long 4 mm mm X-Long 8 mm mm Standard 0 mm mm Long 4 mm mm X-Long 8 mm mm Long 4 mm mm X-Long 8 mm 22 mm heads are available for the small taper femoral components and are impacted directly on the femoral component. Heads are highly polished for reduced friction and wear. Clean and dry stem taper prior to impacting the femoral head or taper sleeve. The modular femoral head component must be firmly seated on the femoral component to prevent dissociation. Modular heads and femoral components should be from the same manufacturer to prevent mismatch of tapers. Scratching of modular heads and tapers should be avoided. Repeated assembly and disassembly of the head/neck component to the femoral stem could compromise a critical locking action of the taper socket joint. The head/neck component should be changed only when clinically necessary. Do not resterilize femoral prostheses with ceramic heads seated on the stem. Acetabular Components Acetabular components are two-piece implants consisting of a titanium shell and a polyethylene liner. Cancellous screws may be inserted through the screw holes in the shell to aid in cup fixation. Tapered pegs may also be used with Reflection V shells to provide adjunctive fixation when desired. Tapered hole covers are available for Reflection V shells. Threaded hole covers are available for Reflection I and V shells. Femoral Components, Universal Heads, Zirconia Ceramic Heads, and Zirconium Alloy Heads are designed for use with any Smith & Nephew Richards UHMW polyethylene acetabular component or UHMW polyethylene-lined, metal backed acetabular component having an appropriately sized inside diameter. INDICATIONS, CONTRAINDICATIONS, AND ADVERSE EFFECTS General The general principles of patient selection and sound surgical judgment apply. The specific components chosen will be largely dependent on the patient s age, general condition, condition of available bone stock, any prior surgery, and anticipated further surgeries. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Indications Porous Coated Total Hips Systems are indicated for uncemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Some of the diagnoses listed above and below may also increase the chance of complications and reduce the chance of a satisfactory result. Contraindications 1. Conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriate size implant, e.g.: a. blood supply limitations; b. insufficient quantity or quality of bone support; c. infections or other conditions which lead to increased bone resorption. 2. Mental or neurological conditions which tend to impair the patient s ability or willingness to restrict activities, especially during the healing period, e.g., drug use, mental illness, senility, and other neurologic conditions. 3. Physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities, etc. 4. Skeletal immaturity. Contraindications may be relative or absolute and must be carefully weighed against the patient s entire evaluation and the prognosis for possible alternative procedures such as nonoperative treatment, arthrodesis, femoral osteotomy, pelvic osteotomy, resection arthroplasty, hemiarthroplasty, and others. Conditions presenting increased risk of failure include: osteoporosis; metabolic disorders which may impair bone formation; and osteomalacia. Possible Adverse Effects 1. Wear of polyethylene articulating surfaces of acetabular components has been reported following total hip replacement. Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces. Higher rates of wear may shorten the useful life of the prosthesis, and lead to early revision surgery to replace the worn prosthetic components. 2. With all joint replacements, asymptomatic, localized progressive bone resorption (osteolysis) may occur around the prosthetic components as a consequence of foreign body reaction particulate matter. Particulates are generated by interaction between components, as well as between the components and bone, primarily through wear mechanisms of adhesion, abrasion, and fatigue. Secondarily, particulates can also be generated by third-body wear. Osteolysis can lead to future complications necessitating the removal and replacement of prosthetic components. See Important Physician Information Section for more information. 3. Loosening, bending, cracking, or fracture of the prosthetic components. 4. Dislocations, subluxation, decreased range of motion, or lengthening or shortening of the femur, caused by improper neck selection, positioning, looseness of acetabular or femoral components or extraneous bone; also penetration of the femoral prosthesis through shaft of femur, fracture of the acetabulum, especially with prior hip surgery, and/or excessive reaming. 5. Fracture of the pelvis or femur. Postoperative pelvic fractures are usually stress fractures. Femoral fractures are often caused by defects in the femoral cortex due to prior screw holes, misdirected reaming, etc. Intraoperative fractures are usually associated with old congenital deformity, improper stem selection, improper broaching, and severe osteoporosis. 6. Infection, both acute postoperative wound infections and late deep wound sepsis. 7. Neuropathies: femoral, sciatic, peroneal nerve, and lateral femoral cutaneous neuropathies have been reported. 8. Wound hematoma, thromboembolic disease including venous thrombosis, pulmonary embolus or myocardial infarction. 9. Tissue reactions: lysis, macrophage and particles and foreign body reaction adjacent to implants, resulting from foreign material in tissues. Also, myositis ossificans, especially in males with hypertrophic arthritis, limited preoperative range of motion and/or previous myositis. 10. Trochanteric nonunion: usually associated with early weight bearing and/or improper fixation of the trochanter, when a transtrochanteric surgical approach is used. 11. Intrapelvic protrusion of acetabular component. 12. Although rare, metal sensitivity reactions in patients following joint replacement have been reported. Implantation of foreign material in tissues can result in histological reactions involving macrophages and fibroblasts. 13. Fatigue fracture of the implant can occur as a result of trauma, strenuous activity, improper alignment, or duration of service. Implants can loosen or migrate due to trauma or loss of fixation. 14. Damage to blood vessels. 15. Temporary or permanent nerve damage resulting in pain or numbness of the affected limb. 16. Traumatic arthrosis of the knee from intraoperative positioning of the extremity.

23 17. Delayed wound healing. 18. Aggravated problems of the affected limb or contralateral extremity caused by leg discrepancy, excess femoral medialization, or muscle deficiency. 19. Periarticular calcification or ossification, with or without impediment to joint mobility. 20. Inadequate range of motion due to improper selection or positioning of components, by femoral impingement, and periarticular calcification. WARNINGS AND PRECAUTIONS Loosening, bending, cracking, and/or fracture of implants and other complications may result from failure to observe the following warnings and precautions. The patient should be warned of surgical risks, and made aware of possible adverse effects. The patient should be warned that the device does not replace normal, healthy bone, and that the implant can break or become damaged as a result of strenuous activity or trauma, and has a finite expected service life and may need to be replaced in the future. Refer to the surgical technique for additional warnings and precautions. Preoperative 1. Use extreme care in handling and storage of implant components. Cutting, bending, or scratching the surface of components can significantly reduce the strength, fatigue resistance, and/or wear characteristics of the implant system. These, in turn, may induce internal stresses that are not obvious to the eye and may lead to the fracture of the component. Implants and instruments should be protected during storage from corrosive environments such as salt air. Do not allow the porous surfaces to come in contact with cloth or other fiber releasing materials. 2. An adequate inventory of implant sizes should be available at the time of the surgery, including sizes larger and smaller than those expected to be used. Extra implant components are recommended. All packages and implants should be thoroughly inspected prior to surgery for possible damage. 3. Patient conditions and/or predispositions such as addressed in Contraindications, above, should be avoided. 4. Allergies and other reactions to device materials, although infrequent, should be considered, tested for (if appropriate), and ruled out preoperatively. 5. Surgical Technique brochures, available on request at no charge, should be reviewed by the surgeon prior to initial surgery. 6. Intraoperative fracture or breaking of instruments can occur. Instruments which have experienced extensive use or excessive force are susceptible to fracture. Instruments should be examined for wear or damage prior to surgery. Intraoperative 1. The correct selection of the implant is extremely important. The appropriate type and size should be weighed against anatomical and biomechanical factors such as patient age and activity levels, weight, bone and muscle conditions, and others; generally, the largest cross-section components which will allow adequate cement and/or bone support to be maintained is preferred. Failure to use the optimum size components may result in loosening, bending, cracking, or fracture of the components, cement, and/or bone. 2. Correct selection of the neck length and cup, and stem positioning, are important. Muscle looseness and/or malpositioning of components may result in subluxation, dislocation, and/or fracture of components. Increased neck length and varus positioning will increase stresses which must be borne by the stem. 3. Prior to seating the liner component into the shell of modular acetabular components, surgical debris must be cleaned from the interior of the shell. Debris may inhibit the liner from locking into the shell component. Failure to properly seat the liner into the shell can lead to dissociation of the liner from the shell. 4. A +12 mm XX-long or longer femoral head should not be used with any of the small taper stems. 5. Distal sleeves should not be used to bridge cortical defects that lie within 25 mm of the tip of the base stem mm heads with a 3 mm neck length are not available for use with the small taper stems. 7. Tight fixation at the time of surgery is critical to the success of the procedure. The femoral component stem must press fit into the femur, which necessitates precise operative technique and the use of specified instruments. Intraoperative fracture of the femur can occur during seating of the prosthesis. Bone stock must be adequate to support the device. 8. If titanium screws or tapered pegs are used for supplemental fixation of the acetabular component, use caution while drilling holes and inserting the bone screws or tapered pegs to avoid vessels, nerves, and visceral structures. A drill guide is recommended for drilling holes and a depth gauge should be used to determine the proper length of bone screws. Clean holes with lavage and suction prior to inserting screws or pegs. Perforation of the pelvis with dome fixation screws or rim screws is to be completely avoided. Care is to be used when determining and selecting the proper length of screws used. Perforation of the pelvis with screws that are too long can rupture blood vessels causing the patient to hemorrhage. ONLY USE REFLEC- TION TITANIUM BONE SCREWS, TAPERED PEGS, AND HOLE COVERS with the Reflection Acetabular Component and ONLY USE OPTI-FIX TITANIUM BONE SCREWS with the Opti-Fix Acetabular Component. Bone screws must be completely seated in the holes of the shell to allow proper locking for the acetabular component liner. The threaded center hole in Reflection shells does not accept screws or pegs, but it does accept the threaded hole cover. The Reflection FSO only accepts cancellous Universal Screws, not pegs or hole covers. Tapered pegs can only be used with Reflection V shells. 9. If the tapered pegs need to be removed from the shell after impaction of the pegs, do not reuse the pegs or the peg shell holes. Use new pegs and different shell holes. 10. With the congenitally dislocated hip, care should be taken to prevent sciatic nerve palsy. Also note that the femoral canal is often very small and straight and may require an extra-small straight femoral prosthesis; however, a regular sized prosthesis should be used when possible. Note that the true acetabulum is rudimentary and shallow. A false acetabulum should not ordinarily be utilized as a cup placement site for anatomical and biomechanical reasons. 11. If components are to be left in place at revision surgery, they should first be thoroughly checked for signs of looseness, cement condition, etc., and replaced if necessary. 12. Care should be taken not to scratch, bend, or cut metal components during surgery for the reasons stated in Number One of the Preoperative Section of Warnings and Precautions, above. The component should be firmly seated with the component insertion instruments. 13. Once removed from the patient, implants previously implanted should never be reused, since internal stresses which are not visible may lead to early bending or fracture of the components. 14. Prior to closure, the surgical site should be thoroughly cleaned of bone chips, extraneous cement, etc. Ectopic bone and/or bone spurs may lead to dislocation or painful or restricted motion. Range of motion should be thoroughly checked for early contact or instability. Malpositioning of either the femoral or acetabular component can result in instability and dislocation. 15. Small taper stems sizes 8S 12L must have a minimum neck length of +8 when used with a bipolar component; and small taper stem sizes 12S 16L must have a minimum neck length of +4 when used with a bipolar component. Postoperative 1. Postoperative directions and warnings to patients by physicians, and patient care, are extremely important. Gradual weight bearing is begun after surgery in ordinary total hip arthroplasty. However, with trochanteric osteotomy or certain complex cases, weight bearing status should be individualized with the non or partial weight bearing period extended. 2. Patients should be warned against unassisted activity, particularly use of toilet facilities and other activities requiring excessive motion of the hip. 3. Use extreme care in patient handling. Support should be provided to the operative leg when moving the patient. While placing the patient on bedpans, changing dressings, clothing, and similar activities, precautions should be taken to avoid placing excessive load on the operative part of the body. 4. Postoperative therapy should be structured to regain muscle strength around the hip and a gradual increase of activities. 5. Periodic X-rays are recommended for close comparison with immediate postop conditions to detect long-term evidence of changes in position, loosening, bending, and/or cracking of components or cement or bone loss. With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of early revision considered. 6. Prophylactic antibiotics should be recommended to the patient similar to those suggested by the American Heart Association for conditions or situations that may result in bacteremia. 7. Failure of the porous coating substrate interface may result in bead separation or delamination. IMPORTANT PHYSICIAN INFORMATION Bone resorption is a natural consequence of total joint arthroplasty due to changes in bone remodeling patterns. Bone remodeling is mediated by the changes in stress distribution caused by implantation. Extensive resorption around the prosthesis leads to implant loosening and failure. Progressive bone resorption due to reasons other than stress shielding or infection has been termed osteolysis. It is generally agreed that osteolysis is the result of localized foreign body reaction to particulate debris generated by cement, metal, UHMWPE, and ceramic. Regarding the etiology, it had been hypothesized that particulate debris generated by the components of a prosthesis migrate into the synovial cavity and the bone implant interface, where they recruit macrophages and stimulate phagocytic action. The degree of recruitment is determined by the size, distribution, and amount of particulate debris (rate of debris generation). The phagocytic action results in the release of cytokines and intercellular mediators (IL-1, 2, PE2) which encourages osteoclastic bone resorption. Clinical and basic research is continuing in order to provide scientific basis for the causes of this phenomenon and potential ways to reduce its occurrence. Osteolysis can be asymptomatic and therefore routine periodic radiographic examination is vital to prevent any serious future complication. Presence of focal lesions which are progressive may necessitate replacement of the prosthetic component(s). PACKAGING AND LABELING Implants should be accepted only if received by the hospital or surgeon with the factory packaging and labeling intact. If the sterile barrier has been broken, refer to the Resterilization section below. STERILIZATION All metal components are provided sterile and have been sterilized by a minimum of 25 kilo Grays of gamma irradiation. Plastic components have been sterilized by ethylene oxide gas. All components are supplied in protective trays. Inspect packages for punctures or other damage prior to surgery. RESTERILIZATION Metal Components Metal components may be resterilized, if necessary, by steam autoclaving in appropriate protective wrapping, after removal of all the original packaging and labeling. Protect prosthesis, particularly mating surfaces, from contact with metal or other hard objects. The following process parameters are recommended for these devices: Prevacuum cycle, 4 minutes at 132 O C to 135 O C, followed by 20 minutes of drying time. If porous coated implants are inadvertently contaminated, return the unsoiled prosthesis to Richards for resterilization. DO NOT RESTERILIZE porous coated implants. The porous coating requires special cleaning procedures. Plastic Components Plastic components may be resterilized by ethylene oxide gas, using the following procedures: Sterilant Temperature Humidity Maximum Concentration Exposure Pressure Time 88% Freon 130 O C % 21 psia mg/l 105 minutes 12% EtO or 40 60% 100 O C 50% 21 psia 650 mg/l 6 hours Suggested aeration time is 12 hours at 50 O C with power aeration. Consult aerator manufacturer for more specific instructions. INFORMATION For further information, please contact Customer Service at CAUTION: (U.S.A.) Federal law restricts this device to sale by or on the order of a physician. 3/95

24 Smith & Nephew, Inc Brooks Road Memphis, TN U.S.A. (901) For information: For orders and order inquiries: Reflection, MicroStable, ExtrusionLock, and Opti-Fix are trademarks of Smith & Nephew, Inc. U.S. Patent Numbers 5,226,917 and 5,310, Smith & Nephew, Inc. 7/