Following an earlier recall in Canada, Stryker announced on the 4th of July they were recalling their Rejuvenate Modular Hip Implant, which has been increasingly scrutinized for causing metallosis and high failure rates in recipients.
The Stryker Rejuvenate hip system was released in February of 2010, touting its modular structure (separate stem and neck rather than all one piece) and its ability to better personalize the implant to a patient’s unique structure and hip biomechanics (Bloomberg). Amidst the pending metal-on-metal hip industry disaster, the polyethylene and ceramic materials made the implant a favorable alternative to fill the void in the market.
However, the femoral head (ball) interface is not the only point at which metal can articulate or wear. The Stryker Rejuvenate Recall details the potential for fretting and/or corrosion at or about the modular neck/stem junction, which is made of cobalt and chromium.
Image from stryker.com – click to view
As we’ve seen with metal-on-metal hip patients, metallic ions seeping into the bloodstream can cause a number of problems including adverse local tissue reactions manifesting with pain and/or swelling. Many people need an additional (revision) surgery shortly after their first surgery, when the implants are supposed to last at least a decade. Revision surgeries bring even more risk and vulnerability to the patient.
The Stryker Rejuvenate Modular Hip System, like many orthopedic implants, was passed through the FDA’s 510(k) clearance program. This means that no clinical trials were done to test the safety of the product because they were able to prove it was “substantially equivalent” to a similar product on the market. Sadly, equivalent didn’t necessarily mean safe. Existing modular hip systems at that time had already started to fail, and there were many MAUDE Adverse Event Reports filed detailing similar problems that the Rejuvenate now shows.
In April, Stryker released a Field Safety Notice to surgeons warning them of the risks associated with the product. Now, you can see their recall notice on their website.
If you or a loved one received the Stryker Rejuvenate Hip Implant, or have been experiencing swelling, pain or symptoms of metallosis after your recent (post-2009) hip replacement surgery, YOU MAY BE ENTITLED TO COMPENSATION.
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Related articles
- FDA panel finds little use for metal-on-metal hip implants – CBS News (cbsnews.com)
- FDA Probing Safety of Metal-on-Metal Hip Implants (health.usnews.com)
- Hip Implant Concerns Reached 16800 in a Decade, FDA Says – Bloomberg (bloomberg.com)
- More Controversy of MoM Devices (defectivedruganddeviceresourcecenter)
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