Optetrak 200-04-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862039712), received between Jul 1, 2020 and Jan 13, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K932776); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 123 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT AN ARTHROSCOPY PROCEDURE DUE TO SYNOVITIS AND LOOSENING. PATIENT BEGAN EXPERIENCING PAIN, POPPING, CLICKING AND CATCHING OF THE RIGHT KNEE AFTER A FALL APPROXIMATELY 7 MONTHS PRIOR. ARTHROSCOPIC SURGERY OPERATIVE NOTES WERE PROVIDED. POSTOPERATIVE DIAGNOSIS INDICATED SYNOVITIS, TIBIAL COMPONENT LOOSENING, METALLOSIS, AND FRACTURED TIBIAL POLYETHYLENE WITH LOOSE FRAGMENTS. SURGEON PERFORMED A THREE COMPARTMENT SYNOVECTOMY AND LOOSE BODY REMOVAL FROM WITHIN THE NOTCH. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO INTRAOPERATIVE OR POSTOPERATIVE COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Metal Related Pathology; Pain; Peeling; Synovitis

  MAUDE report 21143942 ↗
• InjuryOct 4, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - (B)(6). PATIENT ID: (B)(6). 10/3/24: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 10/2/24. ATTACHED EMAIL, ARTHROSCOPY OP REPORT, AND REVISION OP REPORT. THE PATIENT HAD A FALL IN (B)(6) OF 2022. SHE WAS WALKING UP SOME STEPS, LANDED ON THE ANTERIOR ASPECT OF HER KNEE, AND STARTED NOTICING CLICKING, POPPING, CATCHING, AND PAIN WITHIN HER KNEE. PRIOR TO THAT, SHE REALLY DID NOT HAVE ANY MAJOR SYMPTOMS. ATTACHED EXPLORATORY ARTHROSCOPY OP REPORT FROM JANUARY OF 2023 DISCOVERED SYNOVITIS, TIBIAL COMPONENT LOOSENING, METALLOSIS, AND LOOSE AND FRACTURED LATERAL TIBIAL POLYETHYLENE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED FOR PROCEDURE IN (B)(6) 2023. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED FAILED RIGHT TOTAL KNEE ARTHROPLASTY DUE TO SEVERE POLYETHYLENE WEAR DISEASE AND OSTEOLYSIS. DESCRIPTION OF PROCEDURE: UPON ENTERING THE JOINT I FOUND THE SYNOVIAL LINING OF THE JOINT WAS BLACK DUE TO METALLOSIS. INSPECTION OF THE COMPONENTS FOUND THAT THE POSTERIOR ASPECT OF THE POLY INSERT WAS COMPLETELY WORN OUT AND A LARGE PORTION OF THE POSTERIOR LATERAL TIBIAL PLATE WAS ERODED AWAY. THE PREVIOUS LINER WAS DISLODGED FROM THE TIBIAL COMPONENT. I THEN INSPECTED THE FE

  Patient problems: Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 20369930 ↗
• InjuryJul 1, 2020Naturally Worn; Naturally Worn

  AS REPORTED, THERE WAS NARROWING OF THE JOINT SPACE ON THE MEDIAL SIDE ON THE RIGHT KNEE NOTED ON AN X-RAY OF A (B)(6) Y/O FEMALE PATIENT. DURING EXPOSURE THERE WAS EVIDENCE OF OSTEOLYSIS SCRATCHING OF THE FEMORAL COMPONENT COMPLETE WEAR OF THE POLY INSERT AND A WORN HOLE IN THE TIBIAL TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNING, DISPOSED OF BY FACILITY.

  Patient problems: Failure of Implant

  MAUDE report 10219895 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932776. One submission often covers many models, so check the product and lot details in each record.

• Z-0927-06 · Dec 19, 2005 · Terminated
  Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONL
• Z-1379-05 · Jun 2, 2005 · Terminated
  The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SING