United Orthopedic Corporation

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 hip joint replacement. The surgeon should thoroughly understand all aspects of the surgical procedure and limitations of the device. 2. 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. 3. The U-Motion II acetabular components are designed for single use only. Never use prosthetic components which have been used before. 4. 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. 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. 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. Likewise, a ceramic liner with any kind of damage must not be used, but discarded instead. This also applies to a ceramic liner that has fallen to the floor, for example. With ceramic liners that have already been used, there is risk that they could have damages invisible to the naked eye. Since any kind of damage can adversely affect the ceramic’s functionality and/or stability, a safe use cannot be guaranteed. For this reason, only unused and undamaged ceramic liners packaged in their original packaging may be implanted. 7. Exclusively use brand-new components for the configuration of metal shells and inserts, as an exact fit of the insert in the shell must be guaranteed. 8. On rare occasions, in vivo fracturing of the ceramic liner may occur. In order to minimize this risk, the ceramic liner was individually examined before delivery. One cause of failure can be the incorrect fixation of the ceramic liner with the cup. The use of prosthesis components which are not released by UOC for combination with a ceramic liner can also lead to the fracture of the ceramic liner. The same applies if the recommended position of the ceramic liner (inclination/anteversion) is not observed. 9. The position of the prosthesis components has a direct influence on the range of movement and thus represents a potential risk of impingement, luxation or subluxation. For cup casings which are too steep, surface pressure on the acetabular edge increases. This can lead to increased wear and tear. The cup position is oriented in accordance with the safety zone described by Lewinnek. 10.The joint may luxate with strenuous exercise, or subluxate through the impingement of implant components or soft tissues. 11.The inclination of the cup components should not significantly exceed or fall below a value of 40-45°. The anteversion of the cup components should not significantly exceed or fall below a value of 10-20°. Outside this range there are restrictions in movement which can lead to subluxations and/or dislocations of the head from the ceramic liner. For a cup which lies outside the above-mentioned values, a ceramic liner must not be used. For cups in retroversion, no ceramic liners should be used. 12.Bearing areas must always be clean and free of debris prior to assembly. 13.Return all packages with flaws in the sterile barrier to the supplier. Do not resterilize. 14.UOC strongly advises against the use of another manufacturer's femoral component with any UOC acetabular cup component. This device may only be combined with prosthetic components released by UOC for use with this device. U-Motion II acetabular cups can only collocate with Delta ceramic liners or XPE cup liners in this system. Only ever use Delta ceramic liners with UOC ceramic femoral heads. Coupling with a different femoral head or with a ceramic ball from other manufacturers is not allowed. Any such use will negate the responsibility of UOC for the performance of the resulting mixed component implant. 15.Ceramic head replacements (See Fig. 6):-In case a ceramic component breaks, a pairing of metal (ball head) with polyethylene (liner) is contraindicated in a revision. PRECAUTIONS PREOPERATIVE 1. 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’s 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. 2. 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. 3. Enough sizes of the implants should prepare for surgery, including larger and smaller size. Special size is also recommended to prepare. 4. Pay attention to special conditions of patient as the description of contraindication. 5. Preoperative screening should be considered if the materials of the device cause allergy or other reaction of patients although this condition occurs seldom. 6. Radiographic templates are available to assist in the preoperative prediction of component size and style. 7. Surgeon must read the surgical protocol carefully before operation. 8. Check the colored sterilization indicator of the packaging. 9. The labels, especially the size designation the package labels, must be checked to see that they match the labels on the devices. INTRAOPERATIVE 1. The UOC Surgical Protocols provide additional procedural information. 2. Appropriate selection, placement and fixation of the femoral stem and/or acetabular 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, biomechanics 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. 3. If use bone screws with acetabular components, care must be taken not to damage blood vessels, nerves or abdominal tissue when drilling screw holes and inserting screws. Use drill guide before drilling screw holes and measure the depth of drilling by the depth gauge for selecting the proper length of screw. Don’t use screws longer than 50 mm. Bone screws must be completely fixed into the screw hole of the acetabular shell, so that the acetabular liner can properly be embedded within the acetabular shell. 4. Before place the Delta ceramic or XPE cup liner into the cup, make sure that any foreign matter from the prosthesis components, such as tissue particles, bone or cement particles from the surface of the acetabulum cup has been removed. 5. The Delta ceramic or XPE cup liner should be placed and fitted in accordance with UOC’s instructions (see the figures below). 6. At time of assembly, inner taper of the shell must be clean and dry to ensure proper seating and assembly security. 24