Optetrak Logic 02-012-51-2015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862230355), received between Nov 25, 2019 and May 31, 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 31, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 24 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, LOOSENING AND SURGICAL REVISION. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19436266 ↗
• InjuryNov 9, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S KNEE WAS REVISED DUE TO PAIN AND SYNOVITIS. THE SURGEON PERFORMED RELEASES AND IMPLANTED A NEW 15 CRC INSERT WITH GOOD RANGE OF MOTION AND STABILITY. THERE WAS NO SURGICAL DELAY OR ISSUE WITH ANY DEVICES DURING THE REVISION PROCEDURE. THE PATIENT LEFT IN STABLE CONDITION. THE EXPLANT IS NOT AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Synovitis

  MAUDE report 15758396 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, AVERAGE SIZED (B)(6) Y/O FEMALE WITH AN UNSTABLE LEFT KNEE. SURGEON PROCEEDED WITH KNEE REVISION AND IDENTIFIED THE NEED TO REMOVE THE EXISTING TIBIAL INSERT AND REPLACE IT WITH A THICKER VERSION, SO HE WENT FROM A 15MM TO A 17MM CRC INSERT. ALL AVAILABLE INFORMATION RECEIVED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 9368485 ↗