Optetrak Logic 02-012-51-3513Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862230461), received between Jul 13, 2023 and Sep 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.

• InjurySep 25, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA: (B)(4) LK REVISION IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED THAT APPROXIMATELY 78 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Implant Pain; No Clinical Signs, Symptoms or Conditions; Swelling/ Edema; Synovitis

  MAUDE report 20305306 ↗
• InjuryFeb 22, 2024Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST INITIAL LEFT TKA, THE 76 Y/O MALE PATIENT HAD AN ORIGINAL EXACTECH TKA DONE. THE PATIENT RETURNED TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT UNDERWENT A POLY INSERT AND PATELLA IMPLANT SWAP. PATIENT WAS REVISED TO TRULIANT CRC TIBIAL INSERT SZ 3.5, 17MM AND AN OPTETRAK 3 PEG PATELLA. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE IMPLANT(S) IS SENT TO THE LAB AND LEGAL AT THE HOSPITAL. IMAGES, X-RAYS, EBI ATTACHED. NO FURTHER MEDICAL/PATIENT INFORMATION PROVIDED.

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

  MAUDE report 18763457 ↗
• InjuryJul 13, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR, AND THE LINER AND PATELLA WERE EXCHANGED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 17322269 ↗