Optetrak 234-03-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862063267), received between Feb 12, 2020 and Nov 24, 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.

• InjuryNov 24, 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 RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED POLYETHYLENE WEAR AND PAIN. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 16 YEARS AND 6 MONTHS AFTER INITIAL IMPLANTATION. IT WAS LATER OBSERVED THAT THE PATIENT'S FEMORAL COMPONENT HAD DEBONDED. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 23630916 ↗
• InjuryJul 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT, WHO HAD AN INITIAL RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. SEVERE OSTEOLYSIS PRESENT. SEVERE DAMAGE TO THE TIBIAL INSERT. UPON FURTHER INSPECTION, THE FEMORAL COMPONENT HAD LOOSENED. ALL COMPONENTS WERE REMOVED AND REVISED TO ANOTHER SYSTEM. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THE HOSPITAL RETAINED THEM FOR ANALYSIS. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 22661222 ↗
• InjuryJul 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 130 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FAILURE OF LEFT TOTAL KNEE REPLACEMENT SECONDARY TO POLYETHYLENE LINER RESULTING IN BONE LOSS AND A LOOSE TIBIAL COMPONENT AS WELL LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. A LWEAR AND BREAKING OF THE POLYETHYLENE LINER, OSTEOLYSIS, . POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 19794373 ↗
• InjurySep 29, 2022Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON OR ABOUT (B)(6) 2016 DUE TO DEGENERATIVE ARTHRITIS. AFTER, THE PATIENT PRESENTED FOR AN EVALUATION OF HIS RIGHT KNEE AS HE HAD BEEN COMPLAINING OF MECHANICAL COMPLICATIONS AND CHRONIC PAIN. ON OR ABOUT (B)(6) 2022, THE PATIENT HAD REVISION SURGERY DUE TO IMPLANT LOOSENING OSTEOLYSIS AND SIGNIFICANT SYNOVITIS. THE SURGEON NOTED THAT THE FEMORAL COMPONENT WAS COMPLETELY LOOSE AND REMOVED BY HAND AND THAT THE PATELLAR AND TIBIAL COMPONENTS WERE ALSO LOOSE AND VERY EASILY EXTRACTED. THE INSERT WAS NOTED TO BE CRACKED AND FISSURED.

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

  MAUDE report 15502020 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE (B)(6) Y/O FEMALE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2016 BY THE EXACTECH KNEE REPLACEMENT STUDY. THE PATIENT COMPLAINED OF AN INFECTION. PATIENT COURSE WITH PAIN AND FINDINGS OF RADIOGRAPHIC LOOSENING IS SCHEDULED FOR REVISION ON (B)(6) 2019, AND IS PERFORMED WITH PROSTHESIS REMOVAL AND PLACED SPACER. THE CULTURES REPORT ERYSIPELOTHRIX RHUSIOPATHIAE AND IS CONSULTED WITH INFECTIOLOGY AND ANTIBIOTIC MANAGEMENT IS INITIATED, A PATIENT CONTINUES TO BE HOSPITALIZED. THE EVENT IS NOT RELATED TO THE DEVICE BUT RELATED TO THE PROCEDURE. DEVICES ARE NOT RETURNING AND ALL AVAILABLE INFORMATION RECEIVED AT THIS TIME

  Patient problems: Bacterial Infection

  MAUDE report 9699912 ↗