Optetrak 234-03-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862063281), received between Jul 20, 2020 and Nov 19, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA (TOTAL KNEE ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED INSTABILITY, FEMORAL KNEE DEBONDING/LOOSENING, AND A PERIPROSTHETIC FRACTURE AROUND THE INTERNAL PROSTHETIC KNEE JOINT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity; Periprosthetic fracture

  MAUDE report 23598341 ↗
• InjuryJul 2, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 14.5 YEARS AFTER INITIAL TOTAL KNEE REPLACEMENT, THE PATIENT EXPERIENCED INSTABILITY. DURING REVISION, THE IMPLANTS WERE FOUND TO BE LOOSE. THIS EVENT IS NOT RELATED TO A BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: HOSPITAL POLICY.

  Patient problems: Joint Laxity

  MAUDE report 19656557 ↗
• InjuryJun 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT KNEE IMPLANTED IN MAY OF 2009, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 15 YEARS POST THE INITIAL PROCEDURE. REVISION DATE UNKNOWN. THE SURGEON REMOVED THE OPTETRAK PS KNEE DUE TO POLY WEAR. THERE WERE SIGNS OF WEAR ON THE PATELLA AND LINER. THERE WERE ALSO SIGNS OF METALLOSIS. THERE WAS AN ABSENCE OF CEMENT ON A SIGNIFICANT PORTION OF THE BACKSIDE SURFACE OF THE FEMORAL COMPONENT. THE SURGEON REPLACED ALL COMPONENTS WITH A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. LEGAL INDICATED FOR THE REASON. DEVICE IMAGES WERE PROVIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 19620816 ↗
• InjuryMay 31, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 7 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, POLY DELAMINATION, AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19441629 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2012, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT, OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10760079 ↗
• InjuryJul 20, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  MALE, AGE (B)(6), WEIGHT UNKNOWN, INITIAL IMPLANT OF RIGHT KNEE ON (B)(6) 2013. UPON EXPOSURE OF THE KNEE JOINT, IT WAS FOUND THAT THE FEMUR WAS LOOSE AND COULD BE REMOVED BY HAND. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE NOT RETURNING DUE TO THE HOSPITAL WON'T RELEASE IMPLANTS. CONCOMITANT MEDICAL PRODUCTS: OPTETRAK TIBIAL TRAY (CN: 200-04-55, (B)(4)). OPTETRAK TIBIAL INSERT (CN: 204-25-11, (B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 10298969 ↗