Optetrak Logic 02-012-51-5011Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862230577), received between Oct 9, 2023 and May 21, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY TWO YEARS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PATELLA WEAR AND DELAMINATION. THE TIBIAL INSERT AND FEMORAL COMPONENT WERE ALSO EXCHANGED. 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: Osteolysis

  MAUDE report 22063825 ↗
• InjuryMay 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 67 Y/O MALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 3 YEARS POST OP. THE PATIENT WAS REVISED DUE TO FEMUR LOOSENING CAUSED BY OSTEOLYSIS FROM TIBIA POLY AND PATELLA WEAR. ALL COMPONENTS WERE REMOVED AND REVISED BY OTHER COMPANY¿S REVISION KNEE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISPOSED AT HOSPITAL.

  Patient problems: Osteolysis

  MAUDE report 22008799 ↗
• InjuryJun 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 59 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19509828 ↗
• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 129 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A REVISION SURGERY FOR PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19342906 ↗
• InjuryNov 16, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2.5 YEARS POST INITIAL RIGHT TKA, THE 72 Y/O MALE PATIENT WAS REVISED DUE TO POLY WEAR.. THE TIBIAL INSERT COMPONENT WAS REVISED FROM A SIZE 5 11MM, TO A SIZE 5 13MM INSERT. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE DEVICE WAS DISCARDED BY THE HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18148541 ↗
• InjuryOct 25, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 6 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: FAILED TOTAL KNEE. MODERATE FLUID WAS EXPRESSED. THE SURGEON BEGAN THE EXTENSIVE TUMOR LIKE DISSECTION OF SYNOVIUM AND DEBRIS. THIS WAS CARRIED DOWN INTO THE GUTTERS, TAKING CARE TO PROTECT THE NEUROVASCULAR AND LIGAMENTOUS STRUCTURES. THERE WAS MODERATE POSTERIOR POLY WEAR, ANTERIORLY LOOKED PRISTINE. THE PATIENT WAS TRANSFERRED TO RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Cyst(s); Discomfort; Failure of Implant; Pain; Scar Tissue

  MAUDE report 18005747 ↗
• InjuryOct 9, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 3 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2018 DUE TO FAILING PREMATURELY. 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.

  Patient problems: Insufficient Information

  MAUDE report 17895162 ↗