Optetrak 200-25-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862040343), received between Jul 1, 2024 and Sep 9, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT A RIGHT TKA (TOTAL KNEE ARTHROPLASTY). SUBSEQUENTLY, THE POLYETHYLENE BECAME WORN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Discomfort; Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 22999844 ↗
• InjuryDec 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 11 YEARS AFTER THIS PATIENT'S RIGHT TOTAL KNEE ARTHROPLASTY THEY WERE REVISED. PATIENT HAD A POLY EXCHANGE DUE TO PAIN AND POLY WEAR. NO ISSUE WITH THE SURGERY.

  Patient problems: Pain

  MAUDE report 21035160 ↗
• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 148 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS KNEE PAIN AND SUSPICION DUE TO THE PREVIOUS TGA NOTIFICATIONS AND ONGOING ISSUE WITH THE KNEE INSERTS. AS TGA REPORT (B)(4) STATED "THE PATIENT WAS REVISED DUE TO POLY WEAR." THE SURGEON DECIDED TO REMOVE ALL IMPLANTS AND REPLACE WITH A COMPETITOR'S REVISION KNEE SYSTEM. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain

  MAUDE report 19645324 ↗

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