Optetrak 200-25-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862040350), received between Mar 5, 2024 and Jun 11, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0019-2022 · Root cause: Process control · Recall details · FDA record ↗

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 11, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED A PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SOME UNKNOWN MONTHS AFTER A TOTAL KNEE REPLACEMENT SURGERY. THE PATIENT EXPERIENCED PAIN AND OSTEOLYSIS. THE SURGEON REPORTED THE KNEE INSERT WAS BROKEN AND ALL COMPONENTS WERE REMOVED AND REPLACED WITH A DIFFERENT (UNKNOWN) CONSTRUCT. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 22184868 ↗
• InjuryMar 5, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2012 AND THEN APPROXIMATELY 8 YEARS AND 6 MONTHS LATER ON (B)(6) 2020 ALL DEVICES WERE SURGICALLY REVISED FOR POLYETHYLENE WEAR WITH OSTEOLYSIS AND LOOSE FEMORAL/TIBIAL/PATELLAR BUTTON. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18837326 ↗

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