Optetrak Logic 02-012-45-3040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862003973), received between Sep 16, 2019 and Aug 18, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED STIFFNESS, PAIN, OSTEOLYSIS, FEMORAL AND TIBIAL IMPLANT LOOSENING, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. AS A RESULT, APPROXIMATELY TEN YEARS AND ONE-MONTH POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS REVISED TO COMPETITOR'S DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. THE PRODUCTS ARE NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 22829311 ↗
• InjuryMar 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 70 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, DISCOMFORT, OSTEOLYSIS, PAIN AND SYNOVITIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Osteolysis; Pain; Synovitis

  MAUDE report 21506604 ↗
• InjuryDec 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YEARS AND 4 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT HAS DISCOMFORT AND PERIODS OF INFLAMMATION. X-RAY SHOWED SIGNS OF LOOSENING OF THE TIBIAL COMPONENT AND DELAMINATION OF THE INSERT IN BOTH COMPARTMENTS. SLIGHT JOINT EFFUSION, SLIGHT LAXITY. THE PATIENT WAS REVISED. THE TIBIAL INSERT WAS DETERIORATED WHEN REMOVED.

  Patient problems: Discomfort; Inflammation; Joint Laxity; Joint effusion

  MAUDE report 20875377 ↗
• InjuryJul 22, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 4 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS SUFFERING FROM LAXITY, INSTABILITY, AND CHRONIC HYDRARTHROSIS. MACROSCOPIC PE GRANULOMA INDICATED. THE REPORT STATED THE PATIENT HAD ASEPTIC TIBIAL AND FEMORAL LOOSENING 5 YEARS AFTER THE INITIAL PLACEMENT. THE PE WAS CHANGED. NO SURGICAL DELAYS OR DEVICE BREAKAGES WERE REPORTED. NO X-RAYS WERE PROVIDED. THE DEVICE RETURN STATUS FOR ANALYSIS IS UNKNOWN CURRENTLY. THEY HAVE BEEN REQUESTED. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Granuloma; Joint Laxity; Joint effusion

  MAUDE report 19801708 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  INDEX SURGERY: (B)(6) 2014. PENDING REVISION OF THE LEFT KNEE - REASON NOT REPORTED.

  Patient problems: No Information

  MAUDE report 9069828 ↗