Optetrak 234-02-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862063199), received between Feb 12, 2020 and Aug 13, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 134 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, GROOVING AND DELAMINATION OF THE PATELLA RESULTING IN A GROSSLY LOOSE TIBIAL COMPONENT AS WELL AS LOOSENING OF THE FEMORAL COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Insufficient Information; Joint Laxity; Synovitis

  MAUDE report 19974155 ↗
• InjuryJun 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 109 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, BONE LOSS, LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity

  MAUDE report 19523835 ↗
• InjuryDec 23, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY THREE YEARS POST TKA, THE (B)(6) FEMALE PATIENT EXPERIENCED PAIN AND FUNCTIONAL LIMITATION OF THE LEFT KNEE WITH INFLAMMATORY CHANGES IN SURGICAL WOUND, RADIOGRAPHY EVIDENCE LOOSENING OF TIBIAL AND FEMORAL COMPONENT, ORDERS ARE GIVEN IN FIRST TIME WITH SPACER AND CULTURE TAKING. THERE IS NO FURTHER INFORMATION FOUND REGARDING TREATMENT OR A REVISION. THE EVENT IS POSSIBLY RELATED TO THE DEVICE AND TO THE PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 13081981 ↗
• 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 LEFT KNEE REVISION SURGERY ON (B)(6) 2012, DUE TO OSTEOLYSIS. INITIAL SURGERY DATE WAS (B)(6) 2011. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Osteolysis

  MAUDE report 10760054 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2010, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2008. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10702462 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2008, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2008. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10661608 ↗
• InjuryApr 30, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INITIAL IMPLANT: (B)(6) 2014. LEFT KNEE REVISION DATE: (B)(6) 2019, HOSPITAL: UNKNOWN, SURGEON: UNKNOWN AS REPORTED, APPROXIMATELY 5 YEARS POSTOP THE INITIAL IMPLANT, A PATIENT EXPERIENCED A LEFT KNEE DEVICE FAILURE AND WAS DEFECTIVE BECAUSE OF ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS, SUBSTANTIAL AND DEFECTIVE POLYETHYLENE WEAR, INCLUDING PARTICULATE DEBRIS OF THE PLASTIC POLYETHYLENE INSERT FOUND THROUGHOUT THE KNEE AREA, POLYETHYLENE WEAR RESULTING IN LOOSENING OF THE DEVICE AROUND THE WORN POLYETHYLENE INSERT AREA. NO OTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 10013699 ↗
• InjuryFeb 12, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE (B)(6) Y/O FEMALE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2016. THE PATIENT EXPERIENCED AN LEFT ASEPTIC TIBIAL LOOSENING. PATIENT WEIGHS (B)(6) LBS. PATIENT WITH CLINICAL AND RADIOLOGICAL SIGNS COMPATIBLE WITH ASEPTIC LOOSENING OF THE TIBIAL COMPONENT, IS TAKEN TO REVIEW THE TIBIAL COMPONENT OF LEFT RTR, ON (B)(6) 2020, THE FEMORAL COMPONENT IS STABLE IS NOT REVIEWED, PROCEDURE WITHOUT COMPLICATIONS, DISCHARGED ON (B)(6) 2020. THE EVENT IS NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE. DEVICES NOT RETURNING. ALL AVAILABLE INFORMATION RECEIVED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 9700049 ↗