Optetrak 230-03-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862061768), received between Oct 18, 2019 and Apr 30, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 111 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE. THE PATIENT DID VERY WELL INITIALLY, BUT HAS DEVELOPED INCREASING DISCOMFORT AND POLYETHYLENE WEAR WAS INDICATED BY X-RAY. A REVISION OP REPORT WAS PROVIDED. A REVISION TOTAL RIGHT KNEE AND AUTOLOGOUS PLATELET TISSUE GRAFTING WAS PERFORMED. INTRAOPERATIVELY THE SURGEON OBSERVED SIGNIFICANT METAL STAINING ON ALL SURFACES OF THE SYNOVIUM. THE POLYETHYLENE WAS NOTED TO BE DAMAGED POSTEROMEDIALLY. IT WAS NOTED THERE WAS NO BONE LOSS FROM EITHER THE FEMUR OR TIBIAL FOR REMOVAL OF THOSE COMPONENTS. THE PATIENT WAS REVISED TO AN EXACTECH CONSTRUCT AND NOTED TO BE SEATED WELL. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint effusion; Metal Related Pathology; Synovitis

  MAUDE report 21936995 ↗
• InjuryMar 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5 YEARS AND 3 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF THEIR KNEE. UPON EXAMINATION, POLY WEAR AND OSTEOLYSIS WAS EVIDENT. THE PATIENT WAS SCHEDULED FOR A REVISION RIGHT TOTAL KNEE ARTHROPLASTY, POSSIBLE POLY SWAP. THE PATIENT UNDERWENT A FULL KNEE REVISION TO COMPETITOR'S PRODUCTS. THE POLY SHOWED EARLY WEAR AND THE METAL IMPLANTS WERE LOOSE ON THE BONE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE. THERE WAS A GREATER THAN 45 MINUTES SURGICAL DELAY, BUT THERE WERE NO ADVERSE EVENTS AS A RESULT.

  Patient problems: Osteolysis

  MAUDE report 21503727 ↗
• InjuryJan 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 122 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ADVANCED METALLOSIS AND OSTEOLYSIS OF THE FEMUR AND TIBIA. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Metal Related Pathology; Osteolysis

  MAUDE report 21091691 ↗
• InjuryOct 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 51 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FAILURE OF IMPLANT; POLYETHYLENE WEAR, SIGNIFICANT OSTEOLYSIS AND BONE LOSS, LOOSENING OF FEMORAL AND TIBIAL TRAY. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 20399542 ↗
• InjurySep 24, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 140 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, OSTEOLYSIS, SYNOVITIS. 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; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20290759 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), A (B)(6) Y/O. (BMI=0), MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT OF THE RIGHT KNEE ON (B)(6) 2011. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2014, APPROXIMATELY 40 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: Bacterial Infection

  MAUDE report 9699718 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, 163 CM, (B)(6) KG (BMI=28), MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE R KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2010. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A ASYMMETRIC FEMORAL CRUCIATE RETAINED CEMENTED SIZE4 RIGHT (CATALOG 230-03-04, SERIAL (B)(4), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZE 4F/3T (CATALOG 200-04-43, SERIAL (B)(4), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 4 - 9MM (CATALOG 200-24-09, SERIAL (B)(4), AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4). ON (B)(6) 2014, APPROXIMATELY 41 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. THE EXACTECH WERE REMOVED AND REPLACED.

  Patient problems: Bacterial Infection

  MAUDE report 9699672 ↗
• InjuryOct 18, 2019Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  FEMUR AND TIBIA REVISION TO STEMMED COMPONENTS DUE TO IMPLANT WEAR AND LOOSENING. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION DUE TO PATIENT WANTED TO KEEP IMPLANTS.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9208635 ↗