Optetrak Logic 02-012-51-1509Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862230249), received between Jul 11, 2022 and Jun 8, 2026 — classified as 3 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.

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-0021-2022 · 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.

• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REPLACEMENT AND SUBSEQUENTLY DEVELOPED AN INFECTION. THE SURGEON THEN REPLACED THE LINER. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 25429266 ↗
• InjuryAug 24, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2.5 YEARS POST INITIAL RIGHT TKA, THE 73 Y/O FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR. PATIENT HAD A POLY LINER EXCHANGED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE AS THE DEVICE WAS DISPOSED AT THE HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17612255 ↗
• InjuryJul 11, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT PRESENTED WITH PAIN AND MRI SHOWED SYNOVITIS. POLY EXCHANGE WAS DONE TODAY BY SURGEON. MILD SYNOVITIS AND PITTING OF THE INSERT WAS NOTED. PATIENT LAST KNOWN TO BE IS STABLE CONDITION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 14975528 ↗