United Orthopedic Corporation

UNITED U-Motion II + TM Acetabular Components Safety statement DESCRIPTION UNITED U-Motion II Acetabular components include acetabular shell, Delta ceramic and XPE cup liners, Ti cancellous screw and metallic screw-hole covers. It is used with the United U2 hip stems and the ceramic and metallic femoral heads. It is a modular type of product system with hemispherical design with HA/Ti plasma spray (HA cup, HA+ cup) or Ti plasma spray (PS cup, PS+ cup) on the metallic shell. Three types for different screw hole distributions are available ： cluster-hole, no-hole, and multi-hole. Screw holes with spherical geometry are intended for variable screw fixation angle. Delta ceramic and XPE cup liners fit directly into the metallic shell by taper and snap-in locking mechanism, respectively. XPE cup liner is capable of 12 options for angle adjustment. The Delta ceramic liner is a high-purity alumina ceramic compound in accordance with ISO 6474-2. Note: The delta ceramic liners are not for sale in the US. MATERIALS ASTM F-620 Ti alloy (raw materials: ASTM F-136) Acetabular cup, HA / Ti plasma spray or Ti plasma spray ASTM F-1580 Titanium Metallic powder for plasma spray ASTM F-1185 Hydroxylapatite Hydroxylapatite powder for plasma spray ASTM F-136 Ti alloy Ti cancellous screw, screw-hole covers ISO 6474-2 Highly pure aluminum matrix with zirconia reinforcement Ceramic acetabular cup liner--delta ISO 5834/ASTM F-648 extruded highly-cross linked UHMWPE bars XPE cup liner INDICATIONS The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. 4. Correction of functional deformity. 5. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques. The device is intended for cementless use. CONTRAINDICATIONS 1. Any active or suspected latent infection in or about the hip joint 2. Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. 3. Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis. 4. Skeletal immaturity. 5. Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to failure of the fixation of the device or to failure of the device itself. 6. The U-Motion II acetabular components are designed for uncemented application and single use only. 7. For cup positions which are not recommended, Ceramic Liner should not be used. For cup positions which inclination exceed or fall below a value of 40-45°, anteversion exceed or fall below a value of 10-20°, ceramic liner should not be used. Outside this range there are restrictions in movement which can lead to subluxations and/or dislocations of the femoral head from the ceramic liner. For cups in retroversion, no ceramic liners should be used. Possible consequences are an increase in the surface pressure on the cup edge with grain break-out from the ceramic liner associated with increased ceramic debris. Excessive ceramic debris can lead to adverse tissue reactions, loosening of the prosthesis and in extreme cases ceramic breakage. Ensure adequate joint tension is achieved on implantation, as luxation can lead to the adverse results aforementioned listed. POSSIBLE ADVERSE EFFECT 1. While the expected life of total hip replacement components is difficult to estimate, it is finite. These components are made of foreign materials placed within the body for the potential restoration of mobility or reduction of pain. However, due to the many biological, mechanical and physicochemical factors, which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone. 2. Dislocation of the hip prosthesis can occur due to inappropriate patient activity, trauma or other biomechanical considerations. 3. Loosening of total hip components can occur. Early mechanical loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis or trauma. Late loosening may result from trauma, infection, biological complications, including osteolysis, or mechanical problems, with the subsequent possibility of bone erosion and/or pain. 4. Fatigue fracture of ceramic liner had been reported although in a small percentage of cases. 5. Acetabular cup fracture may occur in the heavy, physically active individual or when contralateral joint disability results in a disproportionate distribution of weight on the reconstructed joint. 6. Peripheral neuropathies, nerve damage, circulatory compromise and heterotopic bone formation may occur. 7. Serious complications may be associated with any total joint replacement surgery. These complications include, but are not limited to: genitourinary disorders; gastrointestinal disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; myocardial infarction or death. 8. Acetabular pain may occur after acetabular replacement due to loosening of the implant or tissue inflammation. 9. Intraoperative fissure, fracture, or perforation of the femur, acetabulum or trochanter can occur due to impaction of the component into the prepared femoral canal or acetabulum. Postoperative femoral or acetabular fracture can occur due to trauma, the presence of defects, or poor bone stock. Metal sensitivity reactions have been reported following joint replacement 10.Adverse effects may necessitate re-operation, revision, arthrodesis of the involved joint, Girdle-stone and/or amputation of the limb. 11.With all implant devices; asymptomatic, localized progressive bone resorption (osteolysis) may occur around the prosthetic components as a consequence of foreign-body reaction to the particulate matter of cement, metal and/or ceramic. Particulate is generated by interaction between components, as well as between components and bone, primarily through wear mechanisms of adhesion, abrasion and fatigue. Also, particulate can be generated by third-body wear. Osteolysis can lead to future complications, including loosening, necessitating the removal and replacement of prosthetic components. 23