Optetrak 232-03-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862063106), received between May 27, 2025 and Jun 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A 52 YO MALE PATIENT WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 YEARS AND 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO PREMATURE POLYETHYLENE WEAR WITH MASSIVE OSTEOLYSIS. ASSOCIATED WITH A PSEUDOTUMORAL LESION IN THE POPLITEAL AREA SECONDARY TO A FOREIGN BODY REACTION CAUSED BY POLYETHYLENE PARTICLES. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Osteolysis

  MAUDE report 22319933 ↗
• InjuryMay 27, 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 97 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FRACTURE OF THE POLY LINER AND POSTERIOR MEDIAL TIBIAL COMPONENT, METALLOSIS, INSTABILITY, LIMITED MOBILITY, SWELLING, KNEE PAIN, AND A GRINDING SENSATION. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. X-RAYS REVEALED METAL ON METAL BILATERAL ARTICULATION WITH FRACTURE POSTERIOR MEDIAL RIGHT TIBIAL COMPONENT AS WELL AS POLY AND FRACTURE LEFT POSTERIOR LATERAL TIBIAL COMPONENT AND POLY. INTRAOPERATIVE FINDINGS INDICATED SEVERE BLACK TISSUE STAINING/METALLOSIS THROUGHOUT THE KNEE AND OSTEOLYSIS OF THE FEMORAL. THE POLY LINER WAS TO HAVE SEVERE WEAR. THERE WAS MILD LOOSENING OF FEMORAL COMPONENT. THE TIBIAL COMPONENT HAD FRACTURED POSTERIOR MEDIALLY WHERE THE METAL FEMORAL COMPONENT HAD BEEN ARTICULATING WITH THE METAL POSTERIOR EDGE OF THE TIBIAL COMPONENT. MULTIPLE SMALL FRAGMENTS OF THE FRACTURED POLY WERE PRESENT AND REMOVED. THE PATELLA HAD SEVERE WEAR PRESENT. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THE PATIENT APPEARED TO HAVE TOLERATED THE PROCEDURE WELL AND W

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Swelling/ Edema

  MAUDE report 22091412 ↗