United Orthopedic Corporation

7. For ceramic liner insertion, fix the ceramic liner centrally in place in the metal shell with the greatest of care, following the diagrams below (Figs. 1~5) provided for this purpose. A perfect fit of the ceramic liner in the cup must ensue. 8. Before the final fitting of the Delta ceramic liner with a plastic impactor, the correct fit of the liner should be tested with the finger. Never bring a metal hammer into contact with the Delta ceramic liner. 9. For XPE cup liner insertion, ensure the tabs on the liner are aligned with the indentions in the shell. Impact firmly with the mallet until the liner is fully seated. The liner should sit flush with the face of the shell. 10.Care must be taken to protect the components from being marred, nicked or notched as a result of contacting with metal or abrasive objects. 11.Care should be taken not to cut through surgical gloves when handling any sharp-edged orthopedic device. 12.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. - Before a decision is made to implant a Delta ceramic or XPE cup liner, a sample inlay made of plastic is placed into the cup and the stem components are implanted. Please take care that the plastic insert will be removed after checking. - The joint is tested for free movement and stability using sample heads of the intended diameter. Please take care that the plastic femoral head will be removed after checking. - The joint may not luxate with movement, or subluxate through the impingement of implant components or soft tissues. POSTOPERATIVE 1. Postoperative care and instructions for patients are very important. Postoperative weight bearing must increase gradually and individually. 2. After postoperative, patients must be reminded, do not make large movement of hip 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 hip 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. Should consider the use of antibiotics in patients to prevent bacterial infection. PACKAGING AND LABELING 1. This device is sterile and double packaged to ensure the product is suitable for surgery at any time. The sealed package can protect the implants and keep the sterilized condition under normal storage and transport. 2. The packaging of all products should be inspected for their integrity and should only be accepted with proper packaging and labeling intactness. 3. All implants should be stored in their original packaging in a clean and dry environment. 4. If the sterile blister pack became wet or damaged, the implants should not be used and be returned to the supplier. STERILIZATION 1. All implants are supplied sterile and have been packaged in protective trays. The method of sterilization is noted on the package label 2. Ceramic and metal components are sterilized by gamma radiation at at least 25 kGy, while the plastic components are ethylene oxide sterilized. All components can be verified from the colored sterilization indicator on the packaging. 3. The packaging of all sterile products should be inspected for flaws in the sterile barrier before opening. In the presence of any flaws, the product must be assumed nonsterile. Special trial prostheses are available to avoid having to open any aspect of the sterile package prior to component use. 4. This device delivered in sterilized form and must be kept unopened in the original packaging until it is ready to be used. Check the sterilization expiry date on the sterile packing and check the protective packing for damage prior to use. If the sterilization expiry date has passed or in case of any damage to the protective packaging, the implants must not be used or re-sterilized and must be discarded or returned to the supplier. 5. Aseptic methods must be followed when removing the component from its original packaging and during the entire implantation. In the event of contamination, this product must be discarded. 6. Ceramics sterilized by gamma rays may be changed in color. This has no influence on the strength or any other characteristic of the ceramic liners. RE-STERILIZATION If the package is opened, but the product is not used, the component must not be resterilized (including Delta ceramic and XPE components) and must be returned to the supplier. A suitable handling will be done. HA / Ti plasma spray cup needs special clean procedures and ceramic components cool down quickly after sterilization with high temperature could affect their mechanical properties. STORAGE AND HANDLING 1. All implants must be stored unopened in the original packaging. 2. The protective packaging must be inspected for signs of damage before the devices are removed, since this could affect the sterility. The sterility expiry date must be observed. If the protective packaging is damaged or the sterility date has passed, the implants must be returned to UOC.Protection may only be removed directly before use. 3. The implants which can no longer be used may be returned to the manufacturer for correct disposal. 4. Ceramic liners are extremely sensitive to damage. Even small scratches or impact points can cause wear, tear or fracture and lead to complications. Extremely careful handling is therefore required. Interaction with drugs There have been no reported interactions with drugs to date. SAFETY INFORMATION IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT U-Motion II Acetabular Components have not been evaluated for safety and compatibility in the MR environment. U-Motion II Acetabular Components have not been tested for heating or migration in the MR environment. 25