Optetrak Logic 02-010-04-0360Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862158413), received between Jan 8, 2025 and Jan 8, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 5 YEARS AND 8 MONTHS AFTER INITIAL IMPLANTATION OF LEFT TOTAL KNEE ARTHROPLASTY IN (B)(6) 2016, IT WAS REPORTED VIA LEGAL NOTIFICATION THAT A PATIENT EXPERIENCED PROGRESSIVE/INCREASED PAIN AND SWELLING ASSOCIATED WITH ASEPTIC LOOSENING. THE PATIENT WAS SURGICALLY REVISED IN (B)(6) 2022, ADDITIONALLY NOTING RADIOGRAPHS SHOWED LOOSENING ABOUT THE FEMORAL COMPONENT. THERE WAS AN ABUNDANT SYNOVIAL INFLAMMATION PRESENT. INSPECTION OF THE COMPONENTS SHOWED THAT THERE WAS EVIDENCE OF WEAR DEBRIS ON THE MEDIAL FEMUR POLYETHYLENE POSTERO-MEDIALLY. THERE WAS OBVIOUS LOOSING OF THE FEMORAL COMPONENT. THE TIBIAL COMPONENT WAS SECURELY FIXED. THE PATELLA WAS IN APPROPRIATE POSITION. THE KNEE WAS STABLE AFTER REVISION. NO COMPLICATIONS DURING THE SURGICAL PROCEDURE. THERE ARE NO RADIOGRAPHIC IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21106666 ↗