United Orthopedic Corporation

41 U2 Mobile Bearing Knee System Safety statement DESCRIPTION The U2 Mobile Bearing Knee System include femoral components, patellar components, tibial trays and tibial inserts which are designed to be used together to achieve total replacement of the knee joint. These components are available without porous coating. The femoral components are posterior stabilized designs. The tibial tray components has groove for cement fixation. Tibial inserts are available in a range of thicknesses and freely rotated with metallic tibial baseplate. Posterior Stabilized inserts have raised tibial eminence for increased anterior and posterior constraint, prevention of posterior subluxation and varus/valgus stability. The patellar components are available in all plastic in-set and on-set designs with dome shape configurations. Materials: ASTM F75 Co-Cr-Mo alloy Femoral component, Tibial baseplate ISO 5834-2 UHMWPE Tibial insert, Patella INDICATIONS The U2 Mobile Bearing Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is indicated for moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. It is also indicated for revision of failed previous reconstruc- tions where sufficient bone stock and soft tissue integrity are present. CONTRAINDICATIONS The U2 Mobile Bearing Knee System is contraindicated in patients with any active or suspected latent infection in or about the knee joint. Patients without sufficient bone stock to provide adequate support and/or fixation to the prosthesis. Patients without sufficient soft tissue integrity to provide adequate stability. Patients with either mental or neuromuscular disorders which would create an unacceptable risk of prosthesis instability or complications in postoperative care, and in patients whose weight, age or activity level might cause extreme loads on the prosthesis and early failure of the system. ADVERSE EFFECTS Potential adverse effects include infection, loosening of the components, breakage or bending of the components, or change in position of the components. Dislocation can occur due to inappropriate patient activity, trauma or other biomechanical considerations. Loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis, component malalignment, osteolysis or trauma. Breakage or bending may result due to inadequate support of the component by the underlying bone or poor component fixation. Wear of polyethylene components has occurred and literature reports have associated its occurrence with bone resorption, loosening and infection. Other potential adverse effects of total knee surgery include genitourinary disorders; gastrointestinal disorders; neurovascular damage, thromboembolic disease, myocardial infarction and other less common adverse effects. Adverse effects may necessitate reoperation, revision, arthrodesis of the involved joint, and/or amputation of the limb. Due to the many biological, mechanical and physicochemical factors which affect these devices, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone. WARNINGS AND PRECAUTIONS Familiarity with and attention to appropriate surgical Technique for total knee arthroplasty and the U2 Mobile Bearing Knee System is essential for success of the total knee procedure. Only surgeons who have reviewed the literature regarding total knee surgery and have had training in the technique should utilize the device. Patients should be instructed the limitations of the prosthesis, including, but not limited to, the impact of excessive loading through patient weight or activity, and be taught to govern their activities accordingly. If the patient is involved in an occupation or activity which includes substantial walking, running, lifting, or muscle strain, the resultant forces can cause failure of the fixation, the device, or both. The prosthesis will not restore function to the level expected with normal healthy bone, and the patient should not have unrealistic functional expectations. Accordingly, strict adherence to the indications, contraindications, precaution and warnings for this product is essential to potentially maximize service life. Appropriate selection, placement and fixation of the total knee components are critical factors that affect implant service life. As in the case of all prosthetic implants, the durability of these components is affected by numerous biologic biomechanic and other extrinsic factors, which limit their service life. The surgeon must not allow damage to polished bearing surfaces because this may accelerate wear of the components. Discard all damaged or mishandled implants. Never reuse an implant. Reuse of this product will cause the risk of cross infection and unpredictable health threat. Keep bearing areas clean and free of debris prior to assembly. Components of the U2 Mobile Bearing Knee System should not be used with those of another manufacturer's total knee component since articular and dimensional compatibility cannot be assured. Intentional removal of the plastic tibial insert after its assembly into the tibial tray results in the destruction of the plastic insert. Care should be taken not to nick or notch the surface of the tibial tray during insert removal. Return all packages with flaws in the sterile barrier to the supplier. Do not resterilize. UTILIZATION AND IMPLANTATION Selection of the U2 Mobile Bearing Knee System depends on the requirement of the patient. The surgeon should become thoroughly familiar with the technique of implantation of the prostheses by: (1) appropriate reading of the literature and (2) training in the operative skills and techniques required for total knee arthroplasty surgery. The trial components should be used for size determination, trial reduction and range of motion evaluation. Radiographic templates are available to assist in the preoperative prediction component size and style. The UHMWPE plugs may be removed from the screw holes, and bone screw may be used for additional fixation. The U2 Surgical Protocols provide procedural information. PACKAGING, LABELING AND STERILIZATION All U2 Mobile Bearing implants have been sterilized by gamma radiation. The packaging of all sterile products should be inspected for their integrity and should be accepted only with proper packaging and labeling intact. Care should be taken to prevent contamination of the component. In the event of contamination, this product must be discarded. If the package is opened, but the product is not used, the component must not be resteril- ized and must be discarded or returned to the supplier. IMPORTANT FOR OPENED COMPONENTS The plastic components, if opened, are not permitted be re-sterilization by any method. The metal components, if opened, please return to United Orthopedic Corporation. A suitable handing in cleaning (if necessary), packaging and gamma radiation will be done.