Optetrak Logic 02-012-51-2513Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862230386), received between Apr 21, 2023 and Dec 29, 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.

• InjuryDec 29, 2025Naturally Worn; Lack of Effect; Naturally Worn; Lack of Effect

  IT WAS REPORTED THAT A 73 YO MALE PATIENT, WHO HAD A LEFT TKA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED BACK TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR LEFT TOTAL KNEE. ADDITIONAL INFORMATION PROVIDED INDICATED THE PATIENT HAD A LOSS OF RANGE OF MOTION. THE PATIENT WAS SCHEDULED FOR A REVISION LEFT TKA POSSIBLE POLYETHYLENE SWAP AND SUBSEQUENTLY UNDERWENT A TIBIAL POLY IMPLANT SWAP AND PATELLA IMPLANT SWAP. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY IMAGES WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED BY THE HOSPITAL. NO IMAGES OF THE EXPLANTED DEVICES WERE PROVIDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 23918050 ↗
• InjuryApr 21, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  PER A REPORT FROM THE LEGAL DEPARTMENT A FEMALE PATIENT (DOB (B)(6) 1951) HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. OP REPORT: THE SURGEON REPORTED THAT THERE WAS EXCESSIVE SYNOVITIS CHARACTERISTIC OF THIRD BODY WEAR FROM POLYETHYLENE DEBRIS. THE TIBIA HAD EXTENSIVE OSTEOLYSIS AND LOOSENING. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain; Synovitis

  MAUDE report 16784226 ↗