Optetrak Logic 02-012-44-3017Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862248107), received between Apr 22, 2024 and Apr 22, 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.

• InjuryApr 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 67 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 5 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON WITH A RECALLED POLY INSERT AND WAS SCHEDULED FOR A REVISION OF THEIR RIGHT KNEE. THEY UNDERWENT A FULL REVISION AND WERE REVISED TO A COMPETITOR¿S DEVICES. THERE WAS A 30-45 MINUTE SURGICAL DELAY WITH NO ADVERSE EVENT TO THE PATIENT AS A RESULT. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS. THEY ARE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19160906 ↗