Optetrak 200-04-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862039798), received between Sep 19, 2024 and Jan 23, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2025Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (B)(4) PATIENT ID: (B)(6). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 9 YEARS AND 5 MONTHS AFTER INITIAL IMPLANT. PER OPERATIVE REPORT NOTES (NOT ATTACHED): WEAR THROUGH THE POLYETHYLENE AND INTO THE METAL OF THE TIBIAL TRAY CAUSING SIGNIFICANT EBURNATION OF METALLOSIS. PER SURGEON NOTES: SIGNIFICANT METALLOSIS AND EROSION OF THE BONE AND SIGNIFICANT OSTEOLYSIS ON BOTH SIDES OF THE JOINT.NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, (B)(4), AND PENDING IN THE EASTERN DISTRICT OF (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIE

  Patient problems: Failure of Implant; Metal Related Pathology; Osteolysis

  MAUDE report 21223775 ↗
• InjurySep 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION 8 YEARS AND 6 MONTHS AFTER A RIGHT TOTAL KNEE ARTHROPLASTY A PATIENT DEVELOPED WORSENING RIGHT KNEE PAIN AND SWELLING AND WAS SURGICALLY REVISED. OPERATIVE NOTES INDICATE NEGATIVE FOR ACUTE INFLAMMATION AND EVIDENCE OF CHRONIC INFLAMMATION INTRAOPERATIVE FINDINGS INCLUDE POLYETHYLENE WEAR WITH OSTEOLYSIS AND LOOSE FEMORAL, TIBIAL AND PATELLAR BUTTON, AS WELL AS FEMORAL CONDYLE BONE LOSS. THERE WERE NO COMPLICATIONS WITH REVISION AND PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION THERE IS NO OTHER INFORMATION AVAILABLE. NO IMAGES WERE PROVIDED.

  Patient problems: Implant Pain; Inflammation; Joint effusion; Osteolysis; Unspecified Infection

  MAUDE report 20258426 ↗

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