Optetrak Logic 02-012-51-3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862230423), received between Apr 22, 2020 and Aug 11, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Naturally Worn

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 50208180 ↗
• InjuryMar 6, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A 73 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE PATIENT PRESENTED BACK TO THE OFFICE. THE ORIGINAL POLY IMPLANT WAS INVOLVED IN THE RECALL. A POLY SWAP WAS PERFORMED DUE TO POLY RECALL/WEAR. THERE WAS A 30-45 MINS SURGICAL DELAY DURING THE PROCEDURE AS THE SURGEON HAD ISSUES INSERTING THE NEW POLY. THERE WERE NO ADVERSE EVENTS AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT WAS DISCARDED BY THE HOSPITAL. NO FURTHER INFORMATION.

  Patient problems: Bone Fracture(s); Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 16492197 ↗
• InjuryJul 26, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 54 YO FEMALE PATIENT, INITIAL IMPLANT ON THE LEFT SIDE ON (B)(6) 2017, UNDERWENT A REVISION APPROXIMATELY 4 YEARS 6 MONTHS POST PROCEDURE TO EXCHANGE A 3X13 POLY FOR A 3X15 POLY DUE TO POLY WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Failure of Implant

  MAUDE report 15108410 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) Y/O MALE PATIENT CALLED AND STATED APPROXIMATELY 18 MONTHS POST OP FROM THE INITIAL IMPLANT, HE STARTED HAVING SWELLING, PAIN, KNEE FELT UNSTABLE AND WORSENED WITH TIME. THE PATIENT STATES THE SURGEON STATES THE DEVICE HAD ¿CAME APART¿ AND NEEDED TO BE REPLACED. STATES HE IS DOING WELL AFTER THE REVISION, BUT WAS MORE PAINFUL THAN RECOVERING FROM THE INITIAL IMPLANT. DEVICES WILL NOT BE RETURNED PUT WILL SEND PICS ONCE HE HAS RECEIVED THE DEVICES.

  Patient problems: Pain

  MAUDE report 9985767 ↗