Optetrak Logic 02-012-44-1509Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862173430), received between Jul 2, 2019 and Feb 18, 2025 — 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.

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 18, 2025Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4), PATIENT ID: (B)(6) + LEFT KNEE, (B)(4) RH IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 95 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394581 ↗
• InjuryJul 2, 2019Unstable; Naturally Worn; Device Slipped; Unstable; Detachment of Device or Device Component; Naturally Worn

  INDEX SURGERY OF OPTETRAK KNEE COMPONENTS OF THE RIGHT KNEE IN 2015. REVISION DUE TO PAIN IN (B)(6) 2018. FEMALE PATIENT UNDERWENT REVISION AND SAID THAT A ¿NUCLEAR¿ ANALYSIS SHOWED THE IMPLANT WAS COMING APART OR DEBONDING.

  Patient problems: Implant Pain; Joint Laxity; Pain; Synovitis

  MAUDE report 8754797 ↗