Optetrak Logic 02-010-04-0230Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862158246), received between Nov 8, 2024 and Aug 11, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Report #2 of 3 for this event.It was reported this patient had an initial left total knee arthroplasty. Subsequently, four (4) years, nine (9) months later, the patient underwent a revision procedure due loosening as a result of polyethylene prosthesis wear. All devices were revised. The Patient was last known to be stable following the event. Images of the explants were provided. No additional information is available.

  Patient problems: Insufficient Information

  MAUDE report 50203104 ↗
• InjuryMar 6, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL LEFT SIDE TKA, THE FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR. PATIENT WAS REVISED INTO A LOGIC PS TKR. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED AT THE HOSPITAL, NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21538475 ↗
• InjuryNov 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 2 YEARS AND 12 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 20645419 ↗