Optetrak Logic 02-012-35-3517Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862247391), received between Oct 12, 2021 and May 6, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 92 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis; Synovitis

  MAUDE report 19251576 ↗
• InjuryMar 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED BY LEGAL, APPROXIMATELY 4.5 YEARS POST OP THE FIRST REVISION OF THE LEFT TKA, THIS MALE PATIENT UNDERWENT A SECOND REVISION AND A NEW OPTETRAK DEVICE TIBIAL INSERT WAS PLACED. REASON FOR THE REVISION WAS NOT REPORTED. UPON INFORMATION AND BELIEF, PATIENT REQUIRED SEVERAL REVISION SURGERIES FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING.

  Patient problems: Failure of Implant

  MAUDE report 16478681 ↗
• InjuryOct 12, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 4 MOS. POSTOP THE LAST LTKA, THIS (B)(6) Y/O MALE PATIENT WAS COMPLAINING OF PAIN AND INSTABILITY. PATIENT¿S LTKA HAD BEEN REVISED ONCE BEFORE IN 2017. PATIENT WAS REVISED TO SZ 3.5, 17MM PSC. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12619047 ↗