United Orthopedic Corporation

89 -Cancer: There is presently no scientific evidence that links polyethylene debris with cancer. However, the possibility cannot be ruled out. -Lymphadenopathy and accumulation in other tissues/organs: There have been a few reports of the accumulation of wear debris in lymph nodes (proximate and distal). Although no medical complications or disease process has been reported as stemming from these accumulations, their existence should be recognized to facilitate diagnosis and avoid confusion with suspicious lesions, cancerous or otherwise. -Systemic disease: There has been some speculation that there could be an association between migration of debris and as yet unidentified systemic effects. It is possible that some long-term effect may be demonstrated at some point in the future, but because there is very little scientific data suggesting association between migration of debris and systemic disease, it is believed that the benefits of these devices clearly outweigh the potential risks for any such theoretical long-term effect. WARNINGS 1.This device should only be applied by qualified and specially trained surgeons who have the corresponding knowledge and experience in the field of knee joint replacement. The surgeon should thoroughly understand all aspects of the surgical procedure and limitations of the device. 2.Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and placement of the implants are important considerations in the successful utilization of the system by the surgeon. 3.Surgeon must inform the patient about the relative information of this device, including its effects and the possible risks during operation, possible post-surgical complications, as well as inspect the materials biocompatibility of the products used with this device. 4.Factors outside the control of UOC are not UOC’s responsibility, including any modification after delivering to the hospitals and any mishandled pre-operation, intra-operation or post-operation. The operating surgeon shall be responsible for any negative effects and complications resulting from non-compliance with the user instructions, improper treatment of the material or an incorrect assessment of indications. 5.If the product does not meet the specifications, please immediately notify the supplier, and dilate the problems that occur. If possible, please return the product to the supplier. 6.Return all packages with flaws in the sterile barrier to the supplier. Do not resterilize. 7.Only unused implants taken from the original packaging may be used. Never reuse an implant again, even though it may appear undamaged. Reuse of this product will cause the risk of cross infection and unpredictable health threat. Besides, there may be visually nondelectable flaws that could reduce the service life of the implant. 8.Discard all damaged or mishandled implants. 9.Care should be taken not to cut through surgical gloves when handling any sharp-edged orthopedic device. 10.Bearing areas must always be clean and free of debris prior to assembly. 11.The joint may luxate with strenuous exercise, or subluxate through the impingement of implant components or soft tissues. 12.Except general instruments, this device may only be implanted combined with UOC implants by using the instruments released by UOC. Any improperly use will negate the responsibility of UOC. 13.Some instruments in the U2 Knee System contain magnets. All U2 Knee magnetic instruments should be kept away from a patient’s active implantable medical device(s) (i.e. pacemaker) when not in use at the surgical site. PRECAUTIONS PREOPERATIVE 1.Only patients that meet the criteria described in the indications should be selected. 2.Pay attention to special conditions of patient as the description of contraindication. 3.Surgeon must read the surgical protocol carefully before operation. 4.Before clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and limitations of the device. Surgeon must inform the patient that an artificial joint cannot be subjected to the same demands as a natural joint, and the patient should not have unrealistic functional expectations. Surgeons should instruct patients about 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. Any kind of competitive sport, i.e. sport types with jolting or jerking movements, involving the artificial joint is contraindicated and leads to excessive strains. 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. An additional risk is posed by patients with high body weight, with a weak osseous system or by those who are physically very active. Brief, extreme overloading such as a trauma, an accident or excessive strain can lead to fracturing, sometimes long after the event. The patient also must be informed of possible post-surgical complications. 5.Enough sizes of the implants should prepare for surgery, including larger and smaller size. Special size is also recommended to prepare. 6.The implant must be carefully preserved and transported properly. Cut or scratch the surface of the implant will significantly reduce its static, fatigue strength or influence its friction characteristics. These may have small defects and internal stress patterns invisible to the naked eye which may lead to early failure of the device. Implants and instruments are not stored in the salt air. 7.Check the colored sterilization indicator of the packaging. 8.To check the label information, especially the size designation, is consistent with the device. 9.The recommended trial components should be used for size determination, trial reduction and range of motion evaluation, thus preserving the integrity of the actual implants and their sterile packaging. INTRAOPERATIVE 1.The UOC Surgical Protocols provide additional procedural information. 2.The suggested surgical procedure should be strictly adhered to. 3.Appropriate selection, placement and fixation of the components are critical factors which affect implant service life. As in the case of all prosthetic implants, the durability of these components is affected by biological, biomechanical and other extrinsic factors, which limit their service life. Accordingly, strict adherence to the indications, contraindications, precautions and warnings for this product is essential to potentially maximize service life. 4.Care should be taken not to cut through surgical gloves when handling any sharp-edged orthopedic device. 5.Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel. 6.Before wound closure, any bone fragment or bone cement should be removed from surgical site. Heterotopic bone, bone spurs or bone fragment may cause pain or limitation of activity for patients. 7.The recommended trial components should be used for size determination, canal preparation evaluation, trial reduction and range of motion evaluation, thus preserving the integrity of the actual implants and their sterile packaging. 8.Cemented application: Care should be taken to assure complete support of all parts of the device embedded in bone cement to prevent stress concentrations which may lead to failure of the procedure. Prevent bone cement and all parts of the device from blood and grease. Complete cleaning (complete removal of bone chips, bone cement fragments, and metallic debris) of the implant site is critical to prevent accelerated wear of the articular surface of the implant. Before implantation, replacement of surgical gloves is recommended POSTOPERATIVE 1.Postoperative care and instructions for patients are very important. Detailed instructions on the use and limitations of the device should be given to the patient. Postoperative weight bearing must increase gradually and individually. 2.After postoperative, patients must be reminded, do not make large movement of knee joint individually with no help or without auxiliaries, especially when going to the toilet or performing the higher degree of activities. 3.Moving the patient carefully and paying attention to support the affected area and avoid exerting pressure on it. 4.The postoperative treatment should take care of the strength of muscles around the knee and increase activity gradually. 5.Regular X-rays shall be taken to evaluate if the implant move, loose, bend, fracture or the cement or bone loss. If these conditions occur, please pay attention to the progress of condition and consider the advantage of revision. 6.Usage of antibiotic should be considered to prevent infection. “UNITED” U2 TM Total Knee System Safety Statement