Depuy Synthes Corail AMT Bedienungsanleitung Seite 7

• Single use devices manufactured by DePuy shall not undergo or withstand any form of alteration,
such as disassembly, cleaning or re-sterilization, after a single patient use. Do not reuse single use
devices. Reuse can potentially compromise device performance and patient safety.
• Do not alter or modify implants in any way.
• Patient weight range shall be considered prior to selecting which Corail AMT HA coated stem is
appropriate for use. These stems have been labelled accordingly.
• Quality femoral bone stock is critical to ensure fixation of the femoral stem. The Corail AMT HA
coated stem should not be used for a revision surgery unless there is sufficient available bone stock.
Where there is no sufficient bone stock, it is recommended to use the Corail Revision HA coated
stem.
• Consider bone grafting and other reinforcement techniques, to seat and support the femoral stem
especially when performing revision surgery.
The following conditions, singularly or concurrently, tend to impose severe loading on the affected
extremity, thereby placing the patient at higher risk for failure of the hip replacement:
1. Obesity or excessive patient weight.
2. Manual labor.
3. Active sports participation.
4. High levels of patient activity.
5. Likelihood of falls.
6. Alcohol or drug addiction.
7. Other disabilities, as applicable.
The following conditions singularly or concurrently, tend to adversely affect the fixation of hip
replacement implants:
1. Marked osteoporosis or poor bone stock.
2. Metabolic disorders or systemic pharmacological treatments leading to progressive deterioration
of solid bone support for the implant (e.g., diabetes mellitus, steroid therapies, immunosuppressive
therapies, etc.).
3. History of general or local infections.
4. Severe deformities leading to impaired fixation or improper positioning of the implant.
5. Tumors of the supporting bone structures.
6. Allergic reactions to implant materials (e.g., bone cement, metal, polyethylene).
7. Congenital dysplasia of the hip which may reduce the bone stock available to support the
acetabular cup prosthesis in total hip replacement.
8. Tissue reactions to implant corrosion or implant wear debris.
9. Disabilities of other joints (i.e., knees and ankles).
WHEN THE SURGEON DETERMINES THAT HIP REPLACEMENT IS THE BEST MEDICAL OPTION AVAILABLE
AND DECIDES TO USE A CORAIL AMT HA COATED PROSTHESIS IN A PATIENT WHO HAS ANY OF THE
ABOVE CONDITIONS OR WHO IS SIMPLY YOUNG AND ACTIVE, IT IS IMPERATIVE THAT THE PATIENT BE
INSTRUCTED ABOUT THE STRENGTH LIMITATIONS OF THE MATERIALS USED IN THE DEVICE AND FOR
IMPLANT FIXATION, AND THE RESULTANT NEED TO SUBSTANTIALLY REDUCE OR ELIMINATE ANY OF
THE ABOVE CONDITIONS.
The surgical and postoperative management of the patient must be carried out with due
consideration for all existing conditions. Mental attitudes or disorders resulting in a patient's failure to
adhere to the surgeon's orders may delay postoperative recovery and/or increase the risk of adverse
effects including implant or implant fixation failure.
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