Optetrak 230-02-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862061683), received between Feb 12, 2020 and Jun 30, 2026 — classified as 6 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 16, 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.

• InjuryJun 30, 2026Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  REPORT #1 OF 3 FOR THIS EVENT IT WAS REPORTED VIA LEGAL DOCUMENTATION A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ONE (1) YEAR LATER, THE PATIENT UNDERWENT A REVISION OF THE TIBIAL INSERT AND FEMORAL COMPONENTS. NO MEDICAL OR CLINICAL INFORMATION WAS PROVIDED. ADDITIONALLY, IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT CONTINUES TO EXPERIENCE DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND INCLUDING BUT NOT LIMITED TO GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; METALLOSIS; SOFT TISSUE DAMAGE; INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology; Osteolysis; Pain; Unspecified Infection

  MAUDE report 25670320 ↗
• InjuryMar 11, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT, INITIAL LEFT TOTAL KNEE UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2024. THE PATIENT UNDERWENT A FULL KNEE REVISION TO A COMPETITOR¿S PRODUCT. THE POLY SHOWED SOME OXIDATION AND DELAMINATION. THE PATELLA WAS LOOSE AND CAME OFF THE PATELLA BONE. THE FEMORAL COMPONENT WAS LOOSE AND WAS REMOVED FROM THE BONE. THE TIBIA IMPLANT WAS REMOVED FROM THE BONE. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THERE WAS A 30-45 MINUTE SURGICAL DELAY DURING THE PROCEDURE WITH NO ADVERSE EVENTS TO THE PATIENT AS A RESULT. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. THEY WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21573803 ↗
• InjuryFeb 6, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROTHESIS WEAR, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, DISCOMFORT, METAL RELATED PATHOLOGY, OSTEOLYSIS, PAIN, SCAR TISSUE, AND SYNOVITIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21326842 ↗
• InjuryJan 30, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 9 YEARS POST INITIAL LEFT TOTAL KNEE ARTHROPLASTY (TKA) USING CR SLOPE WITH TIBIAL INSERT, THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT OF ALL KNEE DEVICE WAS PERFORMED. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. ALSO, DAMAGE WAS OBSERVED IN POSTERIOR OF TIBIAL TRAY DUE TO CONTACTING TO THE FEMORAL COMPONENT. THE SURGEON DECIDED TO REPLACE ALL COMPONENTS WITH A COMPETITOR PROSTHESIS. THE TIBIAL TRAY WAS DAMAGED AND FOUND METAL POWDER. THE SURGEON RETRIEVED AND CLEANED IT APPROPRIATELY DURING THE SURGERY. THE PATIENT'S BONE QUALITY WAS NORMAL AND THE PATIENT HAD HIGH ACTIVITY LEVEL. IT WAS ALSO NOTED THAT THE PATIENT HAD NOT WORN A KNEE BRACE FOLLOWING SURGERY. THE EVENT DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint effusion; Pain

  MAUDE report 21280317 ↗
• InjuryMar 2, 2020Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 9 YRS POSTOPERATIVE TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON THIS (B)(6) Y/O FEMALE PATIENT DR. (B)(6) DETERMINED THAT THE COMPONENT HAD FAILED. DR. NEWMAN OPENED THE JOINT IN STANDARD FASHION. HE DECIDED TO TAKE EVERYTHING OUT AND IMPLANT A STRYKER REVISION KNEE. HE THEN CLOSED THE JOINT IN STANDARD FASHION. THE PATIENT LEFT THE OR IN STABLE CONDITION. HOSPITAL DID NOT RELEASE IMPLANTS FOR RETURN TO EXACTECH.

  Patient problems: No Information; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 9774892 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6), A (B)(6) Y/O, 161 CM, (B)(6) (BMI=32), MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT OF THE LEFT KNEE ON (B)(6) 2014. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2017, APPROXIMATELY 35 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 (B)(6); 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 9699916 ↗