Optetrak Logic 02-012-48-6013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862174703), received between Jul 2, 2024 and Jul 2, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL LEFT TKA, THE 63 Y/O MALE PATIENT HAS A HAS RECALLED POLY INSITU, POLY WEAR WAS NOTED RADIOGRAPHICALLY AND REVISION WAS NEEDED. THE PATIENT 'S LINER AND PATELLA WERE EXCHANGED. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN IMAGES OR X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED.

  Patient problems: Insufficient Information

  MAUDE report 19655505 ↗