• Always use a trial prosthesis for trial purposes. Trials must have the same configuration size,
etc., as the corresponding components to be permanently implanted.
• Single use devices manufactured by DePuy (Ireland) have not been designed to undergo or
withstand any form of alteration, such as disassembly, cleaning or re-sterilization, after a
single patient use. Reuse can potentially compromise device performance and patient safety.
• Quality femoral bone stock is critical to ensure fixation of the femoral stem. Consider bone
grafting and other reinforcement techniques to seat and support the femoral stem.
• Do not use the ACTIS DUOFIX Size 0 femoral stem with a modular femoral head offset of
greater than +13mm. The safety and performance of the ACTIS DUOFIX Size 0 stem with a
modular femoral head offset of greater than +13mm has not been established.
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 this 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.
Excessive physical activity or trauma to the replaced joint may contribute to premature failure of
the hip replacement by causing a change in position, fracture, and/or wear of the implants. The
patient should be informed that factors such as weight and activity levels may significantly
affect wear.
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