Howmedica Osteonics Triathlon Hinge Insert recalled for premature wear risk
What this means
Howmedica Osteonics manufactured certain Triathlon Hinge Insert knee implant components using raw material that had aged more than five years, which can develop excessive oxidation. This may cause the implant to wear faster than expected, potentially leading to device fracture, material fragments, or loosening that could require revision surgery.
- If you received this knee implant, contact your surgeon or healthcare provider to discuss whether your device was affected.
- Do not remove or replace the device yourself; consult your surgeon for guidance.
- Watch for signs of implant problems such as increased pain, swelling, or difficulty with knee function, and report them to your doctor promptly.
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-3198-2026More Howmedica Osteonics recalls
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