Optetrak Logic 02-012-48-6009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862174680), received between Aug 29, 2023 and Feb 29, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 8.5 YEARS POST INITIAL RIGHT TKA, THE MALE PATIENT PRESENTED TO SURGEON WITH A SORE KNEE. THE SURGEON DEALT WITH THE KNEE WITH SUSPICION DUE TO THE PREVIOUS TGA NOTIFICATIONS AND ONGOING ISSUE WITH THE KNEE INSERTS. THE SURGEON DECIDED TO REMOVE ALL IMPLANTS AND REPLACE WITH A COMPETITOR'S REVISION KNEE SYSTEM. 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 PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISPOSED BY HOSPITAL.

  Patient problems: Pain

  MAUDE report 18812560 ↗
• InjuryAug 29, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YEARS POST OP INITIAL RIGHT TKA, THIS 69 Y/O MALE PATIENT WAS REVISED DUE TO POLY WEAR. EVERYTHING WAS REMOVED AND REPLACED BY COMPETITORS DEVICES. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT . NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. UNABLE TO OBTAIN PHOTOS/X-RAYS. PRODUCT NOT RETURNING - DISPOSED AT THE HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17641357 ↗