Howmedica Osteonics hip implant components recalled for premature wear risk
What this means
Certain Scorpio + Mobile Bearing and System One Bipolar hip implant components were manufactured with polyethylene material that had aged beyond recommended limits. This aged material can develop excessive oxidation, leading to accelerated wear, material fragmentation, or device failure.
- Contact your orthopedic surgeon or the hospital where your implant was placed if you received one of these devices.
- Ask your surgeon about your specific implant model and lot number to determine if you are affected.
- Report any symptoms such as sudden pain, swelling, or difficulty with your hip implant to your doctor immediately.
The agency's original wording
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3205-2026More Howmedica Osteonics recalls
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