Optetrak 232-02-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862063045), received between Dec 5, 2024 and Jun 23, 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 16, 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.

• InjuryJun 23, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 10 YEARS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PREMATURE POLYETHYLENE WEAR WITH MASSIVE FEMORAL AND TIBIAL OSTEOLYSIS. THE PATIENT WAS REVISED TO A COMPETITOR DEVICE WITH METAPHYSEAL CONES AT THE FEMORAL AND TIBIAL LEVELS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 22306772 ↗
• InjuryDec 5, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 8 YEARS AND 2 MONTHS LATER, AFTER A TOTAL RIGHT REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, FAILURE OF IMPLANT, METAL RELATED PATHOLOGY, JOINT LAXITY, AMBULATION OR POSTURAL DIFFICULTIES, SWELLING/ EDEMA, PAIN AND OSTEOLYSIS. DIAGNOSIS: CATASTROPHIC FAILURE LEFT TOTAL KNEE WITH FRACTURE OF POLY LINER AND POSTERIOR LATERAL TIBIAL COMPONENT WITH METALLOSIS, KNEE PAIN, SEVERE OSTEOLYSIS LATERAL FEMORAL CONDYLE. FINDINGS: INTRAOP PICTURES PER PATIENT CONSENT WERE OBTAINED THAT SHOWED SEVERE BLACK TISSUE STAINING/METALLOSIS THROUGHOUT KNEE AND THIS WAS THOROUGHLY DEBRIDED. MULTIPLE SMALL FRAGMENTS OF FRACTURED POLY PRESENT AND REMOVED. THE METALLOSIS CAUSED OSTEOLYSIS FEMORAL BONE WORSE LATERAL FEMORAL CONDYLE WITH LARGE DEFECT AND FRACTURE OF RIM OF LATERAL CONDYLE WITH LCL STILL INTACT AND THIS WAS DEBRIDED AS WELL. THE TIBIAL COMPONENT HAD FRACTURED POSTERIOR LATERALLY WHERE METAL FEMORAL COMPONENT HAD BEEN ARTICULATING WITH METAL POSTERIOR EDGE OF TIBIAL COMPONENT. THERE WAS SEVERE METALLOSIS STAINING PRESENT ON TIBIAL BONE AS WELL. THE PATELLAR BUTTON HAD SEVERE WEAR PRESENT AS WELL AND

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20859417 ↗