Optetrak Logic 02-012-51-4015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862230515), received between Oct 9, 2023 and Jul 25, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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.

• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN MAY 2018, UNDERWENT A REVISION PROCEDURE IN JULY 2024, APPROXIMATELY 5 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE REPRESENTATIVE INDICATED THE PATIENT WAS REVISED DUE TO GENERAL POLY WEAR LIKELY DUE TO THE RECALL. THE TIBIAL COMPONENT AND NEW POLY WERE IMPLANTED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS AS THEY WERE COLLECTED BY THE FACILITY AS A SPECIMEN. AN IMAGE OF THE POLY LINER WAS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19827178 ↗
• InjuryNov 7, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2020. THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED FOR A REVISION TKA POSSIBLE POLY SWAP VS. FULL REVISION. THE PATIENT WAS REVISED ON 16-OCT-2023. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 18089179 ↗
• InjuryOct 9, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2017. APPROXIMATELY 4 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES, INCLUDING BUT NOT LIMITED TO, SEVERE PAIN, SWELLING, INSTABILITY, MULTIPLE FALLS, AND HAVING TO UNDERGO REVISION SURGERY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A S

  Patient problems: Insufficient Information; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17894332 ↗