Optetrak Logic 02-012-45-2010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862003898), received between Dec 6, 2024 and May 21, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 11 MONTHS AND 29 DAYS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, IN LIGHT OF UNFORESEEN COMPLICATIONS ASSOCIATED WITH THE KNEE PROSTHESIS, THE SURGEON DEEMED IT NECESSARY TO PERFORM REVISION SURGERY. IT WAS IDENTIFIED THAT THERE WAS MOBILIZATION OF THE TIBIA, ACCOMPANIED BY ABNORMAL WEAR OF THE POLYETHYLENE COMPONENT. THE PATIENT UNDERWENT A TOTAL KNEE REVISION AND A COMPETITOR'S PROSTHESIS WAS IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION.

  Patient problems: Insufficient Information

  MAUDE report 22062334 ↗
• InjuryDec 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 112 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, FAILURE OF IMPLANT, SYNOVITIS, OSTEOLYSIS, AND IMPLANT PAIN. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20907527 ↗
• InjuryDec 6, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 7 YEARS AND 1 MONTH AFTER INITIAL IMPLANT. PATIENT HAS EXPERIENCED PROSTHESIS WEAR, OSTEOLYSIS, SWELLING/ EDEMA, SYNOVITIS AND SCAR TISSUE. IT WAS REPORTED IN THE OPERATIVE NOTES EXPIRATION OF THE IMPLANTS REVEALED, PATELLA, FEMORAL AND TIBIAL BASEPLATE WEAR. ALSO NOTED IN THE OPERATIVE FINDING THE PATIENT WAS NOTED TO HAVE ARTHROFIBROSIS IN THE KNEE JOINT. COMPONENTS WERE NOT RETURNED TO EXACTECH FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. PATIENT WAS TAKEN FROM THE OPERATING ROOM TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity; Osteolysis; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20863568 ↗