Optetrak Logic 02-012-45-6060Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862004086), received between Jun 27, 2024 and Jun 27, 2024 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Unstable; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT THE PATIENT, UNDERWENT AN INITIAL RIGHT KNEE REPLACEMENT SURGERY AND THEN APPROXIMATELY 5 YEARS 5 MONTHS POST INITIAL PROCEDURE THE PATIENT WAS REVISED. REVISION OPERATIVE REPORT-PREOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE ARTHROPLASTY. FINDINGS: MASSIVE OSTEOLYSIS, LOOSE TIBIAL COMPONENT. THERE WAS A TREMENDOUS AMOUNT OF FLUID ABOUT THE KNEE CONSISTENT WITH KNOWN PARTICULATE DISEASE AND SYNOVITIS. THERE WAS OSTEOLYSIS ABOUT THE FEMORAL IMPLANT, THERE WAS AN ARE TUNNELING INTO THE POSTEROLATERAL FEMORAL CONDYLE, THIS WAS DEBRIDED. THE TIBIA WAS GROSSLY LOOSE WITH A LARGE DEFECT WITHIN THE MEDIAL TIBIA. THERE WAS ADDITIONAL BONE LOSS POSTEROLATERALLY WHICH CREATED A CORTICAL DEFECT IN THE POSTEROLATERAL THROUGH WHICH MUSCLE CAME THROUGH. THE MEDIAL SIDE WAS ABSENT GOOD BONE. THE PATELLA WAS GROSSLY LOOSE AND WAS REMOVED. ¿THE PATIENT WAS TAKEN TO THE POSTANESTHESIA CARE UNIT IN STABLE CONDITION. HE TOLERATED THE PROCEDURE WELL. THERE WERE NO IMMEDIATE COMPLICATIONS.¿ THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 19629522 ↗