What are centralizers used for when drilling

MICROPORT HIP SYSTEMS This package contains the following languages:

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1 DE MICROPORT HIP JOINT SYSTEMS This package contains the following languages: English (en) Deutsch (de) Nederlands (nl) Français (fr) Español (es) Italiano (it) Português (pt) 中文 - Chinese (sch) Türkçe (tk) Others Please visit our website for languages ​​then click on the Prescribing Information option. For additional information and translations, please contact the manufacturer or your local sales partner. M C 0086 * P MicroPort Orthopedics Inc. MicroPort Orthopedics BV 5677 Airline Rd. Hoogoorddreef 5 Arlington, TN BA Amsterdam U.S.A. The Netherlands * The CE conformity marking applies to individual catalog numbers and can be found on the external label. September 2017

2 Important note for the surgeon IMPORTANT MEDICAL INFORMATION HIP JOINT SYSTEM () OVERVIEW GENERAL NOTES ON USING THE HIP JOINT SYSTEM DEFINITIONS DESCRIPTION A. GENERAL PRECAUTIONS B. ADVERSE EFFECTS E. MANIFICATION AND STERILIZATION E. MANIPULATION AND STERILIZATION G. CLEARANCE AND STERILIZATION G. HIP JOINT BEARING SYSTEM AND PRECAUTIONS H. INDICATIONS I. CONTRAINDICATIONS J. PRODUCT SPECIFIC WARNINGS AND PRECAUTIONS GENERAL INFORMATION ON USING THE HIP JOINT SYSTEM DEFINITIONS Symbols and abbreviations may be used on the packaging label. See the table below for the definitions of these symbols and abbreviations. Table 1. Definition of symbols and abbreviations Symbol g h D Y i H l Definition of batch designation Catalog number Do not reuse Caution, observe enclosed documents Observe operating instructions Can be used up to temperature limit 18

3 p N M P I K Store in a dry place Protect from sunlight Date of manufacture Manufacturer Authorized representative in the EU Sterilized with ethylene oxide Sterilized with radiation Do not re-sterilize Caution: Under US federal law, this product may only be sold by or on the order of a physician. MR Conditional Do not use the product if the package is damaged. Abbreviation Ti Ti6Al4V CoCr Al 2 O 3 ZrO 2 SS PE-UHMW HA PMMA PDLLA PDMS Material Titanium Titanium Alloy Cobalt-Chromium Alloy Aluminum Oxide Zirconia Stainless Steel Ultra-High Molecular Weight Polyethylene Hydroxylapatite Polymethylmethacrylate Poly D, L-Lactic Acid Silicone 55D DESCRIPTION MicroPort Orthopedics Inc. (MicroPort) offers various hip joint endoprostheses. These systems each consist of the following components: acetabular cup, acetabular insert, fixation screws, femoral head, femoral shaft, modular neck, and proximal body. These components can be assembled in various configurations. To avoid mismatching or misalignment of components, only MicroPort components may be used with the exception of pairs of bearings for a MicroPort head, ATF dual mobility acetabular inserts, and ATF Exclusive acetabular inserts (not available in the USA or Canada). 19th

4 The femoral, acetabular, and cement restrictor components are made from a variety of materials. These include cobalt chrome molybdenum alloy, titanium alloy, unalloyed titanium, alumina ceramic, (Biolox Forte diameter mm and Conserve Total BCH femoral head diameter mm), Alumina matrix composite ceramic (Biolox Delta), hydroxyapatite, polymethyl methacrylate (PMMA), poly D. , L-lactic acid (PDLLA), silicone (PDMS) 55D, stainless steel and ultra high molecular weight polyethylene (UHMWPE). All of these materials conform to ASTM, ISO, or internal standards. See Table 1. The implants are for single use only. A. GENERAL PRECAUTIONS Preoperative Precautions The surgeon should evaluate each situation individually based on the clinical presentation of each patient in making any decisions regarding implant selection. The surgeon must be thoroughly familiar with the implant, the instruments and the surgical procedure before the procedure. The surgeon should contact MicroPort for information on product-specific surgical techniques. When selecting patients for surgery, the following factors can determine the ultimate success of the procedure: the patient's weight, level of activity, and occupation. These factors may affect the service life and stability. Overweight patients can place a heavy load on the prosthesis, which can lead to prosthesis failure. The surgeon must take into account the patient's ability and willingness to follow instructions and control their weight and activity levels. Patients with a high level of activity, poor bone quality or high body weight are less likely to be candidates for a narrower femoral implant. No joint replacement system, including the implant-bone interface, can be expected to withstand the same levels of activity and stress as normal, healthy bone. It is also not as strong, reliable, and durable as a natural body joint. The patient should not have unrealistic expectations about function in jobs or activities that involve significant amounts of walking, running, lifting, or muscular effort. Other conditions that may lead to an increased risk of implant failure include, but are not limited to: 1) patients who are unwilling to follow instructions, or whose mental or neurological condition interferes with their ability or willingness to do so; 2) significant bone loss, severe osteoporosis or revision surgery in which an adequate fit of the prosthesis cannot be achieved; 3) metabolic disorders that can affect bone formation; 4) osteomalacia; 5) Conditions that may impair or hinder the healing process (e.g. alcohol consumption or substance abuse, septic ulcer, end-stage diabetes, severe protein deficiency and / or malnutrition); 6) pre-existing ailments or conditions that must be taken into account during surgical interventions of all kinds, such as B. bleeding disorders, long-term treatment with steroids, treatment with immunosuppressants or high-dose radiation therapy. The patient must be warned of surgical risks and informed about possible side effects. The patient should be advised that the prosthesis cannot replace healthy bone, may break or be damaged as a result of activity or trauma, and that it has a limited useful life and may need to be replaced at some point in the future. The patient should also be made aware of any other risks that the doctor may consider worth mentioning. The patient must be made aware that he must inform the surgeon of any noise or unusual sensation, as this may indicate a malfunction of the implant. 20th

5 Intraoperative Precautions The special instruments available must be used to ensure the precise implantation of the prosthetic components. Never use instruments from different manufacturers. While it is rare, instruments can break, especially with intensive use or excessive application of force. For this reason, the instruments should be examined for wear or damage prior to surgery. Before use, examine the instruments for components whose functionality is impaired in an unacceptable manner: Damage that occurred during transport or storage Visible abnormalities, such as B. worn surfaces, blunt edges, corrosion, pitting, cracks or discoloration Difficult to move, lock or connect parts Before use, the implants must be checked for any damage that may have occurred during transport or storage, as well as for defects that increase the likelihood of fragmentation during the Intervention could be investigated. If the condition of a product is unacceptable, contact the manufacturer using the contact information provided at the beginning of this package insert. You will then receive instructions on how to return the product to the manufacturer for inspection. Proper selection of the prosthesis is crucial. Joint prostheses require careful fitting and adequate bone support. The surgeon must select the appropriate implant size with great care and regardless of the endosteal surface of the bone. For the correct implant selection, factors such as implant shape, fixation, patient weight, age of the patient, bone condition, size of the patient, level of activity, level of health prior to the procedure, and the surgeon's experience and familiarity with the device must be taken into account. These factors may affect the service life and stability. The surgeon must inform the patient about these factors. X-ray templates are used to estimate the product size to be used. Ultimately, the patient's anatomy determines the size of the product to be used. The extent of the bone preparation is determined intraoperatively by reaming and / or expanding, starting with the smallest size until the bleeding cancellous bone is reached. Trial prostheses should also be used to assess the position of the final implant and the range of motion of the joint. The final implant size selected during the operation may differ from the size determined during the preoperative planning or the combination selected during the preliminary test phase. Use of cemented prostheses. Care must be taken to ensure that all parts of the prosthesis embedded in the bone cement are fully supported in order to avoid stress concentrations that could lead to failure of the procedure. Thorough cleaning of the treatment site before closure (complete removal of bone splinters, bone cement residues and metal particles) is essential to prevent the joint surfaces of the implant from being worn out prematurely. The PMMA distal centralizers are intended for use as part of a cemented total hip arthroplasty. Use of cementless prostheses. Adequate restraint at the time of the procedure is critical to the success of the procedure. Cementless femoral shafts and acetabular shells must be pressed into the recipient's bone and fit exactly into it, which requires a precise surgical technique and special instruments. The existing bone stock must be suitable for adequate support of the prosthesis. 21

6 22 Postoperative Precautions The patient must be informed that certain restrictions apply to reconstruction treatments and that the entire body weight must not be placed on the implant until it is properly fixed and the site is completely healed. The patient must be instructed to limit their physical activity and to protect the joint endoprosthesis from unnecessary stress and possible loosening, fracture and / or wear and tear. In addition, the patient must follow the doctor's instructions for follow-up examinations and treatment. Loosening the components can lead to increased production of wear particles and damage to the bone, which makes a successful revision procedure much more difficult. Regular and long-term follow-up visits are recommended to monitor the position and condition of the prosthetic components and the condition of the surrounding bone. Follow-up x-rays at regular intervals are recommended for precise comparison with early postoperative conditions in order to be able to detect long-term signs of position changes, loosening, bending or cracking in the components. Implant Fragment Recommendations 1. Immediately after removing the implants from the patient, inspect them for any signs of breakage or fragmentation. 2. If the implant is damaged, keep it to assist the manufacturer in analyzing the event. 3. Carefully assess the risks and benefits of removing the fragment from the body versus leaving it in the patient, and discuss the considerations with the patient (if possible). 4. The patient must be informed about the type and safety of the fragment left in the body, including the following information: a. Material composition, size and location of the fragment (if known); b. Potential injury mechanisms, e.g. B. Dislocation, infection; c. Procedures or treatments to be avoided in the case of a metal fragment, e.g. B. MRI examinations. This can reduce the possibility of serious injury from the fragment. MRI Safety Information MR Conditional, if applicable, has been determined through experimental testing and is indicated by the MR Conditional Symbol shown in Table 1 above on the intermediate packaging of the product. If an unevaluated component is added to the system, the entire system is considered to be unevaluated. In an MRI environment, there are unavoidable risks associated with metal implants, including component migration, heat induction, and signal interference or distortion around the component (s). The heat induction of metal implants is a risk that depends on the geometric shape and material of the components as well as the power, duration and pulse sequence of the MRI device used. Since MRI machines are not standardized, the extent and likelihood of these implants are not known. MicroPort Hip Systems that do not have an MR Conditional symbol on the packaging have not been tested for safety and compatibility in an MR environment. These products have not been tested for heating, migration, or image artifacts in an MR environment. The safety of these products in the MR environment is unknown. Examining a patient in possession of these products could result in patient injury. These components are passive metal implants, which, like all passive implants, reduce the possibility of mutual interference in certain imaging procedures, including but not limited to: Image distortion in MRI examinations and X-ray scattered radiation in CT examinations exist.

7 MicroPort hip joint systems, which have an MR Conditional symbol on the packaging, have been tested experimentally under the following conditions. All CE marked hip products have been tested for safety in an MR environment. Non-clinical tests have shown that items with the MR Conditional symbol on the packaging are only conditionally suitable for examination in an MR environment. A patient with this device can be safely scanned in an MR system under the following conditions: Static magnetic field only with a field strength of 1.5 Tesla and 3.0 Tesla Maximum spatial gradient of the magnetic field of Gauss / cm or less Maximum reported MR system, average whole body absorption rate (SAR) of 2 W / kg with a scan time of 15 minutes Normal operating mode of the MR system Under the scanning conditions described above, it is expected that products with the MR conditional symbol will have a maximum temperature rise of 11.7 C at 1.5 Tesla / 64 MHz and 5.8 C at 3.0 Tesla / 128 MHz after 15 minutes of continuous scanning. In non-clinical tests, the image artifacts from a composite MicroPort hip joint system extended approximately 50 mm from the product when imaging is done with a gradient echo pulse train and a 3.0 T MRI system. B. ADVERSE EFFECTS with total hip arthroplasty include: 1) Osteolysis (progressive bone resorption). Osteolysis can be asymptomatic and therefore regular x-rays must be taken to avoid serious complications. 2) Particle formation with a subsequent increased rate of wear, which makes an early revision necessary. 3) Allergic reactions to the materials; Metal hypersensitivity; or reactions to wear particles that can lead to histological reactions; Pseudotumor and lesions of the ALVAL type (Aseptic Lymphocytic Vasculitis-Associated Lesions). 4) Delayed wound healing; deep wound infection (early or late) that may require removal of the prosthesis. In rare cases, arthrodesis of the affected joint or amputation of the limb may be required.5) A sudden drop in blood pressure intraoperatively due to the use of bone cement; 6) injury to blood vessels or hematoma; 7) Temporary or permanent nerve injuries, peripheral neuropathies and subclinical nerve injuries as a possible consequence of the surgical trauma that lead to pain or numbness in the affected leg; 8) cardiovascular disorders such as venous thrombosis, pulmonary embolism or myocardial infarction; 9) A fatigue fracture of the prosthetic component can result from trauma, strenuous activity, misalignment, incomplete implant fit, long post-implantation period, loss of fixation, pseudarthrosis, or excessive weight. 10) Displacement, migration and / or subluxation of the prosthesis components due to incorrect positioning, trauma, loss of fixation and / or lack of tone of muscles and connective tissue; 11) Periarticular calcification or ossification with or without impairment of joint mobility; 12) Pseudarthrosis of the trochanter due to insufficient attachment and / or early loading; 23

8 13) Trochanteric rupture as a result of excessive muscle tension, premature loading or unintentional intraoperative weakening; 14) Traumatic knee arthrosis due to the intraoperative positioning of the leg; 15) Insufficient range of motion due to incorrect component choice or positioning, femoral entrapment and periarticular calcification; 16) femoral or acetabular perforation or fracture; Femur fracture when inserting the implant; Femur fracture due to trauma or overload, especially if there is insufficient bone available; 17) Unwanted shortening or elongation of the leg; 18) Aggravated discomfort in the affected or contralateral leg due to difference in length of the legs, excessive medialization of the femur or muscular atrophy; 19) pain. C. HANDLING AND STERILIZATION Implants Implants have been sterilized with gamma rays or ethylene oxide. The respective sterilization method is noted on the label on the packaging. Irradiated implants have been irradiated with gamma radiation in a dose of at least 25 and at most 45 kilogray. This product has been sterilized (with the exception of non-sterile products) and can be considered sterile as long as the inner packaging has not been opened or damaged. If the inner packaging is damaged, further instructions must be obtained from the manufacturer. Do not remove the device from the packaging until the correct size has been determined and the surgical site has been prepared for final implantation, maintaining sterility. Always handle the product with powder-free gloves and avoid contact with hard objects that could damage the product. This is particularly important when handling porous and HA-coated prostheses. The porous or HA-coated surfaces must not come into contact with textiles or other fibrous materials. Products labeled as single-use products must not be reused under any circumstances. Reuse of these instruments could potentially cause serious harm to the patient's health. Examples of hazards associated with re-using these instruments include, but are not limited to: significant instrument performance degradation, cross-infection, and contamination. Prostheses must not be resterilized or reused after coming into contact with body tissue or fluids. They have to be disposed of. MicroPort is not responsible for the use of resterilized implants after they have come into contact with body tissue or fluids. WARNINGS: All packaging materials MUST be removed from the implant prior to implantation. Femoral prostheses with ceramic femoral heads on the shaft must not be resterilized. Ceramic, HA, plastic and / or metal / plastic implants must NEVER be steam sterilized. If a component is dropped in the operating room and the metal implants need to be steam sterilized, perform steam sterilization as described below. The cleaning instructions described below are not suitable for implants. 24

9 Instruments Cleaning 1. Separate the components of assembled instruments before cleaning. For instruments with moving parts, move the parts over the entire range of motion during cleaning in order to clean the moving parts in all positions. 2. Rinse with cold tap water to remove any visible contamination. 3. Soak in an enzymatic cleaning solution prepared according to the manufacturer's instructions for 5 minutes. 4. Brush thoroughly with a soft brush and / or pipe cleaner; Use a syringe to repeatedly rinse any very narrow lumens with an enzymatic cleaning solution. 5. Rinse with cold tap water for at least one minute; rinse any very narrow lumens repeatedly using a syringe. 6. Soak in a cleaning solution prepared according to the manufacturer's instructions for 5 minutes. 7. Brush with a soft brush and / or a pipe cleaner; rinse any very narrow lumens repeatedly with cleaning solution using a syringe. 8. Rinse thoroughly with deionized or reverse osmosis water. 9. Ultrasonic clean for at least 10 minutes in an enzymatic cleaning solution prepared according to the manufacturer's instructions. 10. Flush thoroughly with RO / DI water for 1 minute. 11. Dry with a clean, soft, absorbent disposable cloth. 12. Visually check that the instrument is clean. All visible internal and external surfaces must be visually inspected. If necessary, carry out another cleaning until the implant is visibly clean. Note: Brushes (e.g. pipe cleaners) can be used to clean most lumens, but flushing with a syringe is recommended for narrow lumens with a diameter of 1.04 mm and below. Sterilization The minimum recommendations for steam sterilization of MicroPort's reusable instruments are as follows: 1. Double wrap the components in FDA-approved CSR film or similar non-woven material for hospital use. 2. Sterilization in the autoclave with the following parameters: Steam sterilization Type of cycle Parameter Minimum setpoint Pre-vacuum Exposure temperature 132 C (270 F) 132 C (270 F) Exposure time 4 minutes Drying time 20 minutes 3. After sterilization, wrap the component out of the foil. Use the usual sterile technique with powder-free gloves. Ensure that the implants are at room temperature prior to insertion. Avoid contact with hard objects that could potentially damage the implant. 25th

10 These recommendations are made in accordance with the guidelines of ANSI / AAMI ST79: 2006 Table 5 1 and have been developed and tested using specific equipment. Fluctuations in process parameters or changes to the device can impair the safety of the sterilization. For more information, see the MicroPort Instrument Cleaning and Handling Guide. D. STORAGE CONDITIONS All implants must be stored in a clean, dry environment and protected from sunlight and extreme temperatures. CAUTION: Federal law restricts this product to sale by or on the order of a physician. HIP JOINT FEMUR SYSTEM E. INDICATIONS Area of ​​application Total hip joint systems from MicroPort are intended for total hip arthroplasty to reduce or alleviate pain and / or improve hip joint function in patients with complete skeletal growth. Indications 1) non-inflammatory, degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia; 2) inflammatory degenerative joint disease, including rheumatoid arthritis; 3) Correction of functional deformities; and 4) Revision surgery after other treatments or products have failed. Sandblasted surfaces and implant surfaces coated with hydroxyapatite, titanium plasma spray and calcium sulfate are intended for arthroplasty with cementless prostheses. The Limb Conservation System is intended for procedures that require radical resection with replacement of the proximal, distal, or entire femur for the following reasons: 1) Patients suffering from severe hip arthropathy who do not respond to conservative treatment or better alternative surgical treatment appeals to; 2) surgical intervention in severe trauma, revision of hip arthroplasty and / or oncological indications; 3) metastatic diseases (e.g. osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors). The Ultime Hip Stem (not available in the US or Canada) is intended for use for the following reasons: 1) revision after stem loosening in cases of proximal bone loss (Paprosky grade III and IV); 2) periprosthetic femoral fractures and 3) significant bone loss in tumors or revision of a massive implanted prosthesis. 1 Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI / AAMI ST79: 2006). 26th

11 F. CONTRAINDICATIONS The patient must be informed about these contraindications. Contraindications are e.g. E.g .: 1) open infection; 2) distant foci of infection (which can spread hematogenously to the implant site); 3) rapid disease progression as evidenced by joint destruction or bone resorption as seen on x-rays; 4) patients with incomplete skeletal growth (i.e., the patient is under 21 years of age at the time of surgery); 5) Cases in which there is an inadequate neuromuscular status (e.g. previous paralysis, fusion and / or insufficient abductor strength), inadequate bone availability or poor skin coverage in the area of ​​the joint, making the procedure unjustifiable; 6) neuropathy of the joint; 7) hepatitis or HIV infection; 8) neurological or musculoskeletal disease that negatively affects gait or exercise capacity. G. PRODUCT SPECIFIC WARNINGS AND PRECAUTIONS UNDER NO CIRCUMSTANCES should the following metals be combined in NON-ARTICULATED contact points: stainless steel (other than the stainless steel described in ISO) / cobalt chrome alloy. Stainless steel (except the stainless steel described in ISO) / titanium alloy. Stainless steel (except the stainless steel described in ISO) / unalloyed titanium. No attempt should be made to fit the implant beyond the preparation depth of the femur. Forcibly inserting the implant beyond the prepared femur bone can increase the risk of a bone fracture. In some cases, part of the proximal body, with or without a coating, may be visible above the proximal resection level. Smaller size femoral implants are intended for patients with narrower intramedullary canals of the femur. The geometry of these implants is reduced to match the anatomy of the narrower intramedullary canal of the femur. This also reduces the durability and resilience of the implant. Other modular components (femoral head and shafts, modular necks, and proximal body). Avoid scratching the femoral heads, modular necks and the proximal and distal stem cones. Repeated assembly and disassembly of these components can affect the clamping effect of the cone fit. Before reassembly, remove any surgical residue from the inner cone of the proximal body so that it locks properly into place. Make sure the components are snugly fitted to prevent delamination. The femoral head, the neck cone of the femoral component or modular neck, the cone of the body and the inner cone of the proximal body must be clean and dry before assembly. Femoral prostheses with ceramic femoral heads on the shaft must not be resterilized. For special warnings and precautions regarding ceramic femoral heads, see the Hip Joint Support System section below. For the permissible device combinations, please refer to the relevant information on intervention and the notes on the packaging. 27

12 28 Stems and modular necks with 12/14 SLT cone from MicroPort may only be used in conjunction with femoral heads with 12/14 SLT cone from MicroPort. MicroPort 12/14 SLT Cobalt Chrome Femoral Heads are designed for use with cobalt chrome-molybdenum, titanium alloy, and ISO stainless steel femoral components (not available in the US and Canada) with the MicroPort 12/14 SLT Taper. The neck-body or neck-femoral shaft component should only be replaced if clinically necessary. Further information on the appropriate neck extraction technique can be found in the information on the procedure. PROFEMUR A M shanks. (Not available in the USA or Canada) PROFEMUR A M stems of size 1 are only intended for patients weighing less than 60 kg. The modular 15 -Varus necks in long and short versions must not be used with PROFEMUR A M shafts of sizes 1 and 2. Modular necks Heavy patients (> 104 kg) have increased failure rates of the modular PROFEMUR titanium necks with a long offset. This must be taken into account when selecting patients for the use of these implants. Other factors to consider when selecting a patient, such as B. the level of activity cannot be ruled out as potential factors in these defects. For these patients, other prostheses such as B. modular cobalt chrome necks and monoblock hip stems into consideration. Modular cobalt chrome necks must not be used with the following products: Alumina (Biolox Forte) ceramic femoral head (28 mm length) PROFEMUR E hip stem, size 0 PROFEMUR Preserve stems are only intended for use with modular cobalt chrome necks. In the USA ONLY the following shafts are approved for use with modular titanium or cobalt chrome necks: PROFEMUR R-shaft PROFEMUR sand-blasted Z-shaft PROFEMUR RENAISSANCE shaft PROFEMUR LX revision shaft PROFEMUR TL shaft All other shafts are only for use with modular cobalt chrome necks. Neck sleeves may only be used with femoral shafts and necks that have a MicroPort 12/14 SLT taper. Ultime hip stem. (Not available in the USA or Canada) Success depends on proximal bone reconstruction and correct distal fixation (as can be found in the product-related information on the procedure): In the event of massive proximal bone loss, it is recommended to establish perfect metaphyseal stability of the implant and a achieve optimal bone reconstruction through transplantation and / or bone replacement. To avoid damaging the first proximal hole, it is recommended not to drill or fix this hole before the other, distal holes have been drilled and fixed in order not to jeopardize its functionality. Monofilament metal cerclages are recommended for the closure in order to enable a firm fixation of the flap to the implant.

13 Progressive weight loading can only be started with good proximal femoral reconstruction (partial loading through the use of crutches). HIP JOINT POSITIONING SYSTEM H. INDICATIONS Scope of application Total hip joint systems from MicroPort are intended for total hip arthroplasty to reduce or alleviate pain and / or improve hip joint function in patients with completed skeletal growth. Indications 1) non-inflammatory, degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia; 2) inflammatory degenerative joint disease, including rheumatoid arthritis; 3) Correction of functional deformities and 4) revision surgery after other treatments or products have failed.Sand-blasted surfaces and implant surfaces coated with hydroxyapatite and titanium plasma spray are intended for arthroplasty with cementless prostheses. The CONSERVE trays are intended exclusively for arthroplasty with cementless prostheses, with the exception of those trays that have screw holes for additional screw fixation and can be used for both arthroplasty with cemented and cementless prostheses (not available in the USA). Bowls with BIOFOAM metal foam coating are only intended for arthroplasty with cementless prostheses. PROCOTYL C-UHMWPE trays are intended only for arthroplasty with cemented prostheses (not available in the US and Canada). The PROCOTYL PRIME, DM, E, L, O, W and Z trays are only intended for arthroplasty with cementless prostheses (certain versions are not available in the USA and Canada). Modular LINEAGE and DYNASTY trays with a porous coating of metal beads can be used for both arthroplasty with cemented and cementless prostheses. Alumina ceramic femoral heads CONSERVE Total BCH in sizes 50 mm and 54 mm are intended exclusively for patients with gigantism or pseudarthrosis of the acetabulum and for revisions. Note: The CONSERVE resurfacing femoral component (head) is not approved in the United States for use with an acetabular component.Note: Cobalt chrome femoral heads with the 12/14 SLT cone from MicroPort are intended for articulation with UHMWPE inserts only. The CONSERVE metal-on-metal hip joint shells (not available in the USA) are intended for primary use only with full resurfacing with the CONSERVE or CONSERVE A-CLASS resurfacing femoral component. (Canada only) CONSERVE Plus and CONSERVE A-CLASS systems for full resurfacing involve technically demanding operations. Therefore, they may only be used by experienced surgeons who have already performed more than 50 operations with complete hip resurfacing. 29

14 The CONSERVE resurfacing femoral component (head) is for resurfacing the femoral head to reduce or relieve pain and / or improve hip joint function in patients with completed skeletal growth with non-inflammatory degenerative joint diseases such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli or more painful Hip dysplasia provided. The unipolar hemi-head is intended for hemiarthroplasty to reduce or relieve pain and / or improve the hip joint function in patients with completed skeletal growth, as a replacement for the femoral head in cases of degenerative bone disease, trauma, pseudarthrosis or avascular necrosis. The bipolar hip joint system is intended for the following situations: 1) pathological fractures of the femoral neck; 2) pseudarthrosis of femoral neck fractures; 3) Aseptic necrosis of the femoral head or neck and 4) Primary pathology in the area of ​​the femoral head without acetabular deformation in young patients. I. CONTRAINDICATIONS The patient must be informed about these contraindications. Contraindications are e.g. E.g .: 1) open infection; 2) distant foci of infection (which can spread hematogenously to the implant site); 3) rapid disease progression as evidenced by joint destruction or bone resorption as seen on x-rays; 4) patients with incomplete skeletal growth (i.e., the patient is under 21 years of age at the time of surgery); 5) Cases in which there is an inadequate neuromuscular status (e.g. previous paralysis, fusion and / or insufficient abductor strength), inadequate bone availability or poor skin coverage in the area of ​​the joint, making the procedure unjustifiable; 6) neuropathy of the joint; 7) hepatitis or HIV infection; 8) neurological or musculoskeletal disease that negatively affects gait or exercise capacity. Additional contraindications for the CONSERVE resurfacing femoral component (head) are: 1) inflammatory degenerative joint disease; 2) severe osteopenia. Additional contraindications for metal-on-metal bearings (not available in the US) include: 1) patients with moderate to severe renal insufficiency; 2) This femoral component is contraindicated in women of childbearing potential as the effects of elevated metal ion levels on the fetus are unknown. 30th

15 (Canada only; not available in US) CONSERVE Plus and CONSERVE A-CLASS Full Resurfacing Systems are not intended for use in female patients UNLESS they require 50mm heads and there is no evidence of dysplasia. J. PRODUCT SPECIFIC WARNINGS AND PRECAUTIONS The potential long-term biological effects of metal debris and metal ions are unknown. Carcinogenicity has been discussed on various occasions in the literature. However, there is no conclusive evidence from studies of the carcinogenic effects of metal debris and metal ions. For the permissible device combinations, please refer to the relevant information on intervention and the notes on the packaging. NEVER combine modular or fixed storage components from different manufacturers. Exceptions to this are: bearing pairs for one of the following MicroPort heads and an acetabular insert manufactured by ATF with two directions of movement (not available in the USA and Canada) (28 mm S) (28 mm S) PHA04402 (28 mm S) (28 mm M) (28 mm M) PHA04404 (28 mm M) (28 mm L) (28 mm L) PHA04406 (28 mm L) (22.25 M) PPT07034 (22.25 L) bearing pairs for one of the heads of MicroPort and an Exclusif acetabular cup made by ATF (not available in the US and Canada). PHA04408 (32 mm S) PHA04410 (32 mm M) PHA04412 (32 mm L) PHA04414 (36 mm S) PHA04416 (36 mm M) PHA04418 (36 mm L) Femoral heads with cap or collar are not for use with acetabular inserts with double Mobility provided by ATF. If articulating metal / metal (not available in the US) or ceramic / ceramic combinations 2 are used, the components must be from the same manufacturer to ensure that the two components are compatible for tolerance. [The only ceramic / ceramic combination 2 approved in the USA consists of the Alumina (Biolox Forte) LINEAGE ceramic inserts in conjunction with the Alumina (Biolox Forte) ceramic femoral head of the appropriate diameter from 28 to 36 mm.] The networked DYNASTY A -CLASS Poly (UHMWPE) inserts are intended for articulation with the following ceramic femoral heads: Alumina ceramic femoral head (Biolox Forte, diameter mm) Alumina- CONSERVE Total BCH femoral head (diameter range mm) Alumina matrix composite Biolox Delta -Femoral head (diameter range mm) The networked PROCOTYL PRIME A-CLASS and E-CLASS Poly (UHMWPE) inserts are intended for articulation with the following ceramic femoral heads: Alumina- Ceramic femoral head (Biolox Forte, diameter mm) Alumina- CONSERVE Total BCH femoral head (diameter range mm) 2 Please note the additional package insert for ceramic-on-ceramic articulation 31

16 Alumina matrix composite Biolox Delta femoral head (diameter range mm) In addition, the Alumina ceramic femoral heads (Biolox Forte) are intended for articulation with the LINEAGE DURAMER and LINEAGE A-CLASS UHMWPE polyethylene acetabular inserts (diameter mm) . Outside the USA, the Alumina Ceramic 2 Acetabular Inserts (Biolox Forte) are intended for use with the following Biolox Ceramic Femoral Heads: Alumina Ceramic Femoral Head Alumina Biolox Forte Femoral Head Alumina Matrix Composite Ceramic Heads: Biolox Delta- Femoral Head Outside the USA, the Alumina Matrix Composite Acetabular Inserts (Biolox Delta) are designed for use with the following ceramic femoral heads (manufactured by CeramTec and packaged by MicroPort): Alumina Matrix composite ceramic heads: Biolox Delta femoral head Ceramic femoral heads and acetabular inserts 2 must not be placed on scratched or already assembled metal cones, as this can lead to breakage of the ceramic. The breakage of ceramic components is a serious complication. Ceramic products must be handled with care and should not be used if they have been dropped, even if no damage is visible. Only insert ceramic products with a plastic tip. Patients should be advised to report any unusual noises or sharp pain, as these may indicate a fracture of the implant. The decision to revise should not be postponed as ceramic fragments can seriously damage surrounding soft tissue and metal components. Even after carefully removing the fragments, the outcome of a revision due to ceramic breakage can be affected by particles remaining in the tissue. Damage to polyethylene and metal components used in revision procedures due to ceramic breakage has been reported. Surgeons are advised to carefully consider all available implant options on an individual basis. It should be noted that removing all components, including the femoral shafts and acetabular cups, may not prevent faster wear due to ceramic particles in the tissue. Some authors recommend partial or total synovectomy. Fixation screws for the acetabulum. Perforation of the pelvis with dome fixation or edge screws must be avoided at all costs. Care should be taken when determining the correct screw length and selecting screws to avoid perforating the pelvis. Modular acetabular shell / modular acetabular insert. When using fixation screws, they must be fully inserted in order to guarantee stable fixation of the shell and to avoid knocking against the insert component. Before implantation, it must be ensured that the selected shell and insert are compatible. Before inserting the insert component into the shell component, particles must be removed from the interior of the shell and the shell must be dried thoroughly. Particles and liquid can prevent the insert from firmly inserting into the shell component. If the insert is not properly seated in the shell, the insert may come loose from the shell. Avoidance of a mismatch of cones: Modular inserts from MicroPort Orthopedics Inc. may only be used with shell components from the same MicroPort system. Exceptions to this rule are: LINEAGE UHMWPE inserts can also be used in Orion, EHS and Procotyl E, W and Z trays (some designs are not available in the USA and Canada). All MicroPort 18 cone insert components can be used with MicroPort 18 modular acetabular trays. 32

17 The networked DYNASTY A-CLASS poly inserts can be used with ceramic heads or the following metal heads (some designs are not available in the USA): LINEAGE / TRANSCEND femoral head SuperFinished CoCr with SLT cone CONSERVE BFH head with SLT cone CONSERVE A -CLASS BFH -head with SLT cone CONSERVE Total A-CLASS -Femur head with SLT cone The networked PROCOTYL PRIME A-CLASS and E-CLASS poly inserts are to be used with ceramic heads or the following metal heads (some designs are in the USA not available): Femoral head CoCr with SLT cone LINEAGE / TRANSCEND Femoral head SuperFinished CoCr with SLT cone CONSERVE BFH -head with SLT-cone CONSERVE A-CLASS BFH -head with SLT-cone CONSERVE Total A-CLASS -emoral head with SLT-cone (Canada only; not available in the US) CONSERVE metal-to-metal hip braces. Correct positioning of the acetabular component is imperative. Care must be taken that the acetabulum is placed so that the anteversion angle is 15 ± 10. The following situations are associated with an increased risk of loss of function of the CONSERVE and CONSERVE A-CLASS resurfacing femoral components (head): 1) significant difference in leg length and 2) multiple cysts in the femoral head. (Canada only) Suboptimal conditions for a CONSERVE and CONSERVE A-CLASS resurfacing femoral component (head) are: 1) Male 60 years of age; 2) femoral head size <48 mm; 3) ASA class> 2. CONSERVE shells. The CONSERVE series of shells (thick CONSERVE shells, thin CONSERVE shells, CONSERVE shells with a pin, CONSERVE SUPER-FIX shells, CONSERVE QUADRA-FIX shells and CONSERVE) is available on the international markets (bowls are not available in the USA) HA shells) are only intended for use with the CONSERVE resurfacing femoral components / heads and the CONSERVE A-CLASS resurfacing femoral heads. The CONSERVE neck sleeves for full dentures are intended exclusively for use with the Alumina CONSERVE Total BCH femoral heads or the following metal CONSERVE Total A-Class femoral heads. These femoral heads must be used with these modular neck sleeves. Neck sleeves may only be used with femoral shafts and necks that have a MicroPort 12/14 SLT taper. 33

18 Metal CONSERVE Total A-CLASS femoral heads that must be used with CONSERVE neck sleeves for full dentures: 38AC AC AC AC AC AC AC AC AC AC AC5000 The 28 mm alumina ceramic femoral heads (Biolox Forte) with a long neck are intended for use with titanium alloy femoral stems only. All other sizes of Alumina Ceramic Femoral Heads (Biolox Forte) and Alumina Matrix Composite Heads (Biolox Delta Femoral Head) of all sizes are for use with MicroPort titanium alloy, cobalt-chrome, or stainless steel femoral stems (not available in the U.S. or Canada available). Bipolar cups must not be used in combination with femoral heads with a cap or collar. If a removal wrench is used to detach a head from a bipolar shell, the head must be replaced with a new implant to avoid potential damage from scratches. The femoral components made of cobalt chrome-molybdenum, stainless steel (ISO) and titanium with the Orthomet cone are designed as indicated above for use with the femoral heads with the Orthomet cone made of cobalt chrome-molybdenum: Cobalt chrome femoral heads with Orthomet cone: Femoral head with OMET cone , Superfinish, CoCr Hemi-Head with OMET Taper, CoCr These stems can also be used with the following Zirconia ceramic femoral heads (not available in the USA): Ceramic femoral heads with Orthomet taper; Femoral head with OMET cone, Zr. 34