Optetrak Logic 02-012-51-2013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862230348), received between Oct 29, 2024 and Mar 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.

• InjuryMar 18, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA A LEGAL SHORT FORM AND OTHER SOURCES, THAT A 62 YO FEMALE PATIENT, WHO HAD AN INITIAL RIGHT KNEE IMPLANTED WITH RECALLED POLY ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 4 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR RIGHT TKA. THE SHORT FORM INDICATED THE PATIENT SUFFERED IMMENSE PAIN, LOSS OF CONSORTIUM, AND LOSS OF MOBILITY. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. PRE-OPERATIVE DIAGNOSIS FAILED RIGHT TOTAL KNEE ARTHROPLASTY DUE TO INSTABILITY. POST-OPERATIVE DIAGNOSIS FAILED RIGHT TOTAL KNEE ARTHROPLASTY DUE TO INSTABILITY, PROBABLY RIGHT DISEASE, AND FEMORAL COMPONENT DEBONDING. ONCE THE SURGEON ENTERED THE JOINT, THERE WERE A SIGNIFICANT AMOUNT OF SYNOVIAL TISSUE CONSISTENT WITH POLY WEAR DISEASE. SIGNIFICANT POLY WEAR ON THE WEIGHT BEARING PORTION OF THE LATERAL CONDYLE. THE FEMORAL COMPONENT WAS DEBONDED FROM THE UNDERLYING BONE, AND THE TIBIAL COMPONENT WAS IN SIGNIFICANT VARUS MALALIGNMENT. THE PATIENT UNDERWENT A FULL KNEE REVISION TO A

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 21638831 ↗
• InjuryOct 29, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO FEMORAL LOOSENING AND POLY WEAR ON THE PATELLA, WHICH RESULTED IN INSTABILITY. ALL COMPONENTS WERE REVISED. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. ASSOCIATED WITH 1038671-2023-02914 AND 1038671-2024-03158.

  Patient problems: Joint Laxity

  MAUDE report 20560033 ↗