Optetrak Logic 02-010-04-0350Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862158406), received between Dec 12, 2019 and May 28, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 28, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 2 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLY WEAR AND PITTING BEING PRESENT ON THE BEARING SURFACE. THE FEMUR WAS REVISED DUE TO 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 25323122 ↗
• InjuryMar 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL RIGHT TKA, THIS 79 Y/O MALE PATIENT WAS REVISED DUE TO POLY WEAR AND LOOSENING FEMUR. REVISED FROM CR TO PS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING -DISPOSED AT THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 21561041 ↗
• InjuryAug 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP INITIAL RIGHT TKA, THIS MALE PATIENT WAS REVISED DUE TO POLY WEAR AND FEMORAL LOOSENING. THE TIBIAL INSERT AND FEMORAL COMPONENT WERE REVISED WITH NEW COMPONENTS. THERE WAS NO CHANGE IN SIZE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING: DISPOSED.

  Patient problems: Insufficient Information

  MAUDE report 20041722 ↗
• InjuryApr 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE 70 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO FEMUR LOOSENING, OSTEOLYSIS AND POLY WEAR. EVERYTHING WAS REMOVED AND EXCHANGED TO A COMPETITOR'S PRODUCT. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO DISPOSED AT HOSPITAL.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19111897 ↗
• InjuryJan 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 67 Y/O MALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 3 YEARS POST OP. THE PATIENT WAS REVISED DUE TO FEMUR LOOSENING CAUSED BY OSTEOLYSIS FROM TIBIA POLY AND PATELLA WEAR. ALL COMPONENTS WERE REMOVED AND REVISED BY OTHER COMPANY¿S REVISION KNEE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - DISPOSED AT HOSPITAL.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 18498778 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, MALE PATIENT, AGE AND WEIGHT ARE UNKNOWN. REVISION OF LOGIC CR KNEE DUE TO PATELLA PAIN, PATIENT¿S ANATOMICAL PATELLA TO BE RESURFACED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS IT DISPOSED BY HOSPITAL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 9457679 ↗