Optetrak 210-01-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862057402), received between Sep 26, 2019 and Mar 24, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K954208); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, SWELLING, OSTEOLYSIS AND PROSTHESIS WEAR. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 13 YEARS AFTER INITIAL IMPLANTATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Aseptic loosening; Cyst(s); Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 24680613 ↗
• InjuryMar 7, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 57 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, DISCOMFORT, EMOTIONAL CHANGES, IMPLANT PAIN, JOINT LAXITY, OSTEOLYSIS, 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Implant Pain; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 21550690 ↗
• InjuryJan 30, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 116 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, BONE FRACTURE, IMPLANT PAIN, JOINT LAXITY, OSTEOLYSIS, SWELLING/EDEMA, AND SYNOVITIS. INITIAL SURGERY AND 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21276841 ↗
• InjuryJan 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 139 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, FAILURE OF IMPLANT, OSTEOLYSIS, AMBULATION OR POSTURAL DIFFICULTIES, DISCOMFORT, AND PAIN. 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; Discomfort; Failure of Implant; Osteolysis; Pain

  MAUDE report 21069515 ↗
• InjuryAug 2, 2023Unstable; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2013 DUE TO OSTEOARTHRITIS. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 8 YEARS 8 MONTHS POST PRIMARY PROCEDURE. (B)(6) 2022 OPERATIVE REPORT OPERATIVE FINDINGS: GROSS PURULENCE AND INFECTION, LOOSE FEMORAL COMPONENT, LOOSE TIBIAL COMPONENT, WELL-FIXED PATELLAR COMPONENT, ADEQUATE SOFT TISSUE COVERAGE, AORI CLASS FEMUR 2B, AORI CLASS TIBIA 2B. POSTOPERATIVE DIAGNOSIS: PYOGNEIC ARTHRITIS OF RIGHT KNEE JOINT, DUE TO UNSPECIFIED ORGANISM. THE SURGEON NOTED ABUNDANT PURULENCE. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND COMPLETELY DEBONDED FROM THE BONE, WHERE ABUNDANT PURULENCE WAS NOTED IN THE FEMUR AROUND THE IMPLANT, WHICH WAS REMOVED. THE POLYETHYLENE WAS REMOVED AND THE TIBIAL COMPONENT WAS ALSO NOTED TO BE LOOSE WITH SEVERE BONE LOSS AND PURULENCE IN THE BONE. THE PATELLAR BONE HAD OSTEOLYSIS AS WELL OVER THE LATERAL FACET. SHE TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION

  Patient problems: Joint Laxity; Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 17443197 ↗
• InjuryJan 16, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, A (B)(6) FEMALE PATIENT WAS INITIALLY IMPLANTED IN 2010. A RIGHT TKA REVISION WAS UNDERTAKEN ON (B)(6) 2019 FOR ASEPTIC LOOSENING OF THE RIGHT TKA. AFTER THE JOINT WAS EXPOSED, IT WAS DIFFICULT TO REMOVE THE SS SCREW. AFTER SEVERAL ATTEMPTS, IT WAS DECIDED TO ATTEMPT TO UNSEAT THE POLY INSERT FROM THE TIBIA. UPON LIFTING THE TIBIAL INSERT OFF THE TIBIAL TRAY, IT WAS NOTED THAT THE SS SCREW WAS BROKEN. ALL SCREW PIECES WERE RETRIEVED. IT WAS MODERATELY DIFFICULT TO REMOVE THE TIBIAL TRAY AND RESIDUAL STEM EXTENSION THAT HAD HALF THE BROKEN SCREW IN IT. BONE LOSS ON THE FEMUR WAS SIGNIFICANT AND IT WAS THEN DECIDED TO REVISE THE KNEE TO A HINGED PROSTHESIS. IT IS NOTED THAT THE PATIENT REPORTED A FALL SHORTLY AFTER THE INITIAL PROCEDURE IN 2010. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE BEING RETURNED TO THE MANUFACTURER. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 9597013 ↗
• InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE 60 Y/O PATIENT WAS SUFFERING FROM AN INFECTION. A WASH-OUT" PROCEDURE WAS DONE APPROXIMATELY 6 MOS POSTOP HOWEVER THE INFECTION PERSISTED. THE IMPLANTS WERE EXPLANTED APPROXIMATELY 10 MONTHS POSTOPERATIVELY. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION PER HOSPITAL POLICY. THE PATIENT¿S WEIGHT IS 211 LBS. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. INDEX SURGERY: (B)(6) 2018. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION, CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 9125823 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954208. One submission often covers many models, so check the product and lot details in each record.

• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-