Optetrak Logic 02-010-04-0250Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862158284), received between Dec 29, 2023 and May 21, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 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 6 most recent of 6 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 TWO YEARS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PATELLA WEAR AND DELAMINATION. THE TIBIAL INSERT AND FEMORAL COMPONENT WERE ALSO EXCHANGED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 22064139 ↗
• InjuryJan 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL NOTIFICATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY AND WAS THEN SURGICALLY REVISED APPROXIMATELY 5 YEARS, 8 MONTHS FOLLOWING. THE OPERATIVE REPORT STATES: "LEFT KNEE- ASEPTIC LOOSENING, REVISION OF ALL COMPONENTS. PATIENT HAD PROGRESSIVE/INCREASED PAIN AND SWELLING. RADIOGRAPHS SHOWED LOOSENING ABOUT THE FEMORAL COMPONENT. LAB STUDIES ARE NORMAL. FINDINGS: THE SYNOVIAL FLUID WAS CLEAR. THERE WAS AN ABUNDANT SYNOVIAL INFLAMMATION PRESENT. INSPECTION OF THE COMPONENTS SHOWED THAT THERE WAS EVIDENCE OF WEAR DEBRIS ON THE MEDIAL FEMUR POLYETHYLENE POSTEROMEDIALLY. 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. THE FEMORAL COMPONENT REMOVED; THERE WAS A MODERATE DEGREE OF BONE LOSS ON THE LATERAL CONDYLE, MINIMAL BONE LOSS ON THE MEDIAL CONDYLE WITH EXTENSIVE RESORPTION FROM POLYETHYLENE PARTICLE REACTION. TIBIAL COMPONENT SECURELY FIXED AND WAS REMOVED WITH MODEST BONE LOSS. OCCLUSIVE DRESSING WAS APPLIED AND OVERWRAPPED WITH STERILE CAST PADDING, THEN COMPRESSIVE WRAP. T

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 21130724 ↗
• InjuryOct 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 10 MONTHS AND 3 DAYS POST THE PREVIOUS REVISION SURGERY, THE PATIENT UNDERWENT A SECOND REVISION DUE TO PATELLA WEAR AND POLY WEAR; THERE WAS NO CHANGE IN SIZING. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. ASSOCIATED WITH 1038671-2023-02948 AND 1038671-2024-03169. PREVIOUS REVISION REPORTED UNDER 1038671-2023-00115.

  Patient problems: Insufficient Information

  MAUDE report 20481110 ↗
• InjurySep 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 66 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 4 YEARS POST OP. EVERYTHING WAS REVISED DUE TO OSTEOLYSIS/LOOSENING OF FEMUR AS A RESULT OF PATELLA AND TIBIAL INSERT WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 20125273 ↗
• InjuryAug 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4 YEARS AND 3 MONTHS POST THE INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO POLY WEAR AND FEMUR LOOSENING. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19990344 ↗
• InjuryDec 29, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YEARS POST OP INITIAL LEFT TSA, THIS 60 Y/O MALE PATIENT WAS REVISED. THE PATIENT WAS REVISED DUE TO FEMORAL LOOSENING AND OSTEOLYSIS AS A RESULT OF POLY WEAR. THE PATIENT WAS REVISED TO A SIZE 5 FEMORAL COMPONENT AND A SIZE 5 13MM TIBIAL INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 18420577 ↗