Optetrak 208-23-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862054296), received between May 8, 2024 and Jul 24, 2024 — 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.

1 other recall cover devices cleared under the same FDA submission (K954208); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 137 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19820080 ↗
• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT HAD A LEFT KNEE ARTHROPLASTY ON (B)(6) 2012 AND THEN APPROXIMATELY 10 YEARS LATER ON (B)(6) 2022 HAD A SURGICAL REVISION. REVISION OPERATIVE REPORT OF 1 DEC 2022. POST-OPERATIVE DIAGNOSIS- FAILED LEFT KNEE SECONDARY TO WEAR OF THE BEARING SURFACE. PATIENT WAS REVISED TO EXACTECH DEVICES. KNEE WAS DEBRIDED OF EXUBERANT HYPERTROPHIC SYNOVIAL REACTION. THE FEMORAL, TIBIAL, AND PATELLAR COMPONENTS WERE WELL FIXED. THE TIBIAL POLYETHYLENE WAS SEVERELY WORN WITH DELAMINATION AND BREAKDOWN OF THE MEDIAL TIBIAL PLATEAU ARE WITH SEVERE EROSION INTO THE POLYETHYLENE POST. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. NO DEVICE RETURN. THERE IS NO ADDITIONAL INFORMATION PROVIDED/AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Swelling/ Edema; Synovitis

  MAUDE report 19268116 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954208. One submission often covers many models, so check the product and lot details in each record.

• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-