Optetrak Logic 02-010-04-0340Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862158390), received between Oct 26, 2022 and Apr 2, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED FEMORAL LOOSENING SECONDARY TO TIBIAL AND PATELLA POLYETHYLENE WEAR. AS A RESULT, APPROXIMATELY FOUR YEARS EIGHT MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Aseptic loosening

  MAUDE report 24768450 ↗
• InjuryJun 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT TKA, THE 56 Y/O MALE PATIENT WAS REVISED DUE TO POLYETHYLENE WEAR AND FEMORAL LOOSENING, AS A RESULT OF OSTEOLYSIS. THE PATIENT WAS REVISED TO A SIZE 4 FEMORAL COMPONENT AND A SIZE 4 TIBIAL INSERT. THERE WAS BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 22126431 ↗
• InjuryApr 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE 84 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2017. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO FEMUR LOOSENING, OSTEOLYSIS, AND POLY WEAR. 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. X-RAYS AND PHOTOS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISPOSED AT HOSPITAL

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19112506 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION ON (B)(6) 2022, APPROXIMATELY 4 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. REASON FOR REVISION REPORTED WAS LOOSENING DUE TO OSTEOLYSIS. THE IMPLANTS WERE REPLACED WITH COMPETITORS¿ DEVICES. NO FURTHER INFORMATION KNOWN.

  Patient problems: Osteolysis

  MAUDE report 15674304 ↗