Optetrak 234-02-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862063182), received between Nov 2, 2021 and Jan 2, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2025Unstable; 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 136 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS FRACTURE, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, FAILURE OF IMPLANT, OSTEOLYSIS, JOINT LAXITY, SYNOVITIS AND IMPLANT PAIN. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 21055004 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY FIVE YEARS POST TKA, THE PATIENT EXPERIENCED AN INFECTION. PATIENT IS TAKEN TO THE SECOND TIME OF REVIEW ON (B)(6) 2019, A PROCEDURE WITHOUT COMPLICATIONS, DISCHARGED ON (B)(6) 2019 CONTINUES ANTIBIOTIC. THE EVENT IS NOT RELATED TO THE DEVICE OR THE PROCEDURE.

  Patient problems: Bacterial Infection

  MAUDE report 12737051 ↗