Stryker Rejuvenate Modular Neck and Stem
Stryker has recalled its Rejuvenate Modular Hip Neck and Stem because wear and corrosion may cause pain, swelling, tissue death, and the need for a revision. The Rejuvenate is a modular neck and stem system that was designed to be used with the company's total hip replacement prostheses.
Total hip replacements are typically recommended for the following uses:
- Non-inflammatory degenerative joint diseases, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- To correct functional deformities;
- Revision procedures where other treatments or devices have failed; and,
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Rejuvenate stem was approved by the FDA in June 2008 as an extension to Stryker's Modular Hip System product line. Stryker submitted the Rejuvenate stem through the FDA's 510(k) Premarket Notification Process.
By submitting the Rejuvenate stem this way, the Stryker stem did not have to undergo FDA testing. Instead, the stem was approved as an extension of Stryker's Modular Hip System product line because it was substantially similar to other stems used by Stryker and approved by the FDA.
In May 2012, Health Canada announced a recall of Rejuvenate modular necks after Stryker reported that some patients required revision possibly caused by fretting/wear near the modular neck junction. Health Canada is the Canadian federal department responsible for helping Canadians track health issues.
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