Wednesday, July 11, 2012

Stryker recalls certain hip implant products


(Reuters) - Orthopedic implant maker Stryker Corp said it has begun to recall certain modular-neck stems used to correct hip biomechanics, due to potential risks associated with fretting and corrosion.

The company, which has terminated the global distribution of Rejuvenate and ABG II stems, said it would continue to evaluate the data related to these products.

xxx From Stryker web site:

Q: Why are these products being voluntarily withdrawn from the market?
A: While modular neck hip stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, we decided to voluntarily recall these modular-neck stem hip systems because there is a potential for fretting and corrosion at the modular-neck junction which may lead to adverse local tissue reactions.

Q: How would I know if my hip implant is experiencing fretting and corrosion?
A: The incidence of complications associated with modular-neck stems is extremely low. Affected patients may present with symptoms of pain and/or swelling at the local joint site not attributable to other conditions, such as aseptic loosening and periprosthetic sepsis. Patients experiencing pain and/or swelling should speak with their surgeon.

Q: What should I do if I have one of these hips but don’t have any pain or swelling?
A: If you have no symptoms, you should continue to follow the post-operative plan that your surgeon has outlined for you. If you have further questions, please contact the call center at 1-888-317-0200 (U.S. and Canada only).

Q: I have pain and/or swelling around my hip now. What should I do?
A: If you have symptoms of pain and/or swelling in or around your replaced hip, you should schedule an office visit with your surgeon to discuss your symptoms. If you have further questions, please contact the call center at 1-888-317-0200 (U.S. and Canada only).

Q: Is there a chance this issue will affect me in the future if I don't have any symptoms now?
A: The incidence of complications associated with modular-neck stems is extremely low. If in the future you experience pain and/or swelling of the hip, you should schedule an office visit with your surgeon to discuss your symptoms.

Q: I have a Rejuvenate Modular or ABG II Modular implant. Do I need revision surgery?
A: The incidence of complications associated with modular neck stems is extremely low. Affected patients may present with symptoms of pain and swelling at the local joint site not attributable to other conditions such as aseptic loosening and periprosthetic sepsis. Patients experiencing pain and/or swelling should speak with their surgeon.

Q: I don't know if I have Rejuvenate or ABG II, how can I find out?
A: For privacy reasons patients should speak with their surgeons and/or review their medical records for implant identification information.

Q: I don't have Rejuvenate or ABG II, but I do have a Stryker hip. Should I be concerned?
A: This voluntary recall is specific to Rejuvenate Modular and ABG II modular-neck stems only.

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