Optetrak 200-04-34Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862039743), received between May 27, 2025 and May 27, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 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.

• InjuryMay 27, 2025Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

  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 22091378 ↗

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