Stryker Recall on Modular Neck Systems THR's
Modular Neck Stems
Information About the Voluntary Product Recall
Stryker Orthopaedics voluntarily recalled its Rejuvenate Modular and ABG II modular-neck hip stems.
This voluntary recall was initiated due to the potential risks associated with modular-neck stems. These risks include the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.
Please see the FAQs below for more information.
Your Particular Implant
Your surgeon can tell you if you received a Rejuvenate Modular or ABG II modular-neck hip stem, or you may review your medical records for implant identification information. If you have further questions, please contact the call center at 1-888-317-0200 (U.S. and Canada only).
If you have symptoms of pain and/or swelling in or around your replaced hip, you should schedule an office visit with your surgeon and discuss your symptoms. If you have no symptoms, you should continue to follow the post-operative plan that your surgeon has outlined for you.
Frequently Answered Questions:
Below are some frequently answered questions that may help you better understand the current situation:
Q: Why are these products being voluntarily withdrawn from the market?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.
For More Information:
Stryker has also set-up a call center if you would like to speak with someone about your questions.