United Orthopedic Corporation

“UNITED” U2 TM Total Knee System Safety Statement DESCRIPTION The U2 Total Knee System includes femoral components, patellar components, all poly tibial components, tibial baseplate components and tibial insert components which are designed to be used to achieve total replacement of the knee joint. The femoral components are available in Cruciate Retained (CR) and Posterior Stabilized (PS) designs. The CR femoral components include cemented and porous coated types. Tibial Baseplate, CMA design is a modular design to be used with tibial augments, stem extensions and offset the stem adapter. Tibial inserts and all poly tibial components are available in a range of thicknesses and in three design configurations: Cruciate Retained (CR) 、 Posterior Stabilized (PS) and Ultracongruent (UC) designs. CR design increases anterior and posterior bearing geometry surfaces for additional stability against subluxation. PS type raises tibial eminence for increasing anterior and posterior constraint, prevention of posterior subluxation and increasing varus/valgus stability. UC type raises the prominent anterior lip to prevent femur paradoxical anterior sliding during knee flexion, increase contact area for enhancing wear resistance and eliminates the need to prepare a bone box like a PS knee. CR and UC types are designed to collocate with CR femoral component, while PS type is designed to collocate with PS femoral component. Posterior cruciate ligament is excised when using PS and UC types. MATERIALS: Co-Cr-Mo alloy ASTM F75 Femoral component Ti 6Al4V ELI alloy ASTM F136 Tibial baseplate, Tibial baseplate-CMA type UHMWPE ASTM F648 Tibial insert, Patella, ISO5834-1/ISO All poly tibial 5834-2 component Co-20Cr-15W-10Ni ASTM F90 X-ray wire INDICATIONS The device is indicated for use in total knee arthroplasty in skeletally mature patients with the following conditions: 1.Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. 2.Collagen disorders, and/or avascular necrosis of the femoral condyle. 3.Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. 4.Moderate valgus, varus, or flexion deformities. 5.The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. The device includes Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracongruent (UC) type. CR and UC types are designed to collocate with CR femoral component, while PS type is designed to collocate with PS femoral component. For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components and all poly tibial component: This device is a single use implant and intended for cemented use only.This device is a single use implant and intended for cemented use only. For porous coated femoral component: This device is a single use implant and intended for cementless use only. CONTRAINDICATIONS 1.Previous history of infection in the affected joint and/or systematic infection that may affect the prosthetic joint. 2.Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. 3.Skeletal immaturity. 4.Neuropathic arthropathy. 5.Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb. 6.A stable, painless arthrodesis in a satisfactory functional position. 7.Severe instability secondary to the absence of collateral ligament integrity. 8.Total knee arthroplasty is contraindicated in patients who have rheumatoid arthritis (RA) and an ulcer of the skin or a history of recurrent breakdown of the skin because their risk of postoperative infection is greater. RA patients using steroids may also have increased risk of infection. Late infections in RA patients have been reported 24+ months postoperative. 9.Fever or leukocytosis. 10.Pregnancy. 11.Patients who are heavier than 90 kg (200 lb). An overweight patient can produce loads on the prosthesis which can lead to failure of the fixation of the device or to failure of the device itself. POSSIBLE ADVERSE EFFECTS 1.While the expected life of total knee 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.Bone fracture, peripheral neuropathies, nerve damage, circulatory compromise and heterotopic bone formation may occur. 3.Infections that include acute post-operative wound infection and later on deep wound sepsis. 4.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 embolism; myocardial infarction or death. 5.Dislocation can occur due to inappropriate patient activity, trauma or other biomechanical considerations. 6.Loosening of the 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. 7.Breakage or bending may result due to inadequate support of the component by the underlying bone or poor component fixation. 8.Fatigue fracture of the implants occurred in a small percentage of cases. Implants fracture is more likely to occur in the heavy, physically active individual or when contralateral joint disability results in a disproportionate distribution of weight on the reconstructed joint. 9.Malalignment of the prosthetic knee components. 10.Leg length discrepancies. 11.Adverse effects may necessitate reoperation, revision, arthrodesis of the involved joint, Girdlestone and/or amputation of the limb. 12.Wear of polyethylene components has occurred and literature reports have associated its occurrence with bone absorption, loosening and infection. 13.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. Particulate is generated by interaction between components, as well as between components and bone, primarily through wear mechanisms of adhesion, abrasion and fatigue. Secondarily, particulate can also be generated by third-body wear. Osteolysis can lead to future complications, including loosening, necessitating the removal and replacement of prosthetic components. 14.Very small particles from polyethylene components can be shed from the components during normal use and over time. Although most of this debris says in the relevant joint (i.e. contained in the synovium) or is trapped by surrounding scar tissue, microscopic particles can be disseminated (migrate) throughout the body and on occasions have been described as accumulating in lymph nodes and other parts of the body. Although no significant medical complications have been reported as a result of these particles, their migration and/or accumulation in the body have been described in the literature. Given the insufficient time period during which patients with these devices have been followed and the fact that these devices are currently being used in younger patients and remain in the body for increasingly longer periods of time, it should be said that the long-term effects, if any, from these particles, is unknown. The long-term effects have been theorized to included: 88