BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK FEMORAL COMPONENT

    MDR report key: 21232481 · Received January 24, 2025

    Report

    Report Number
    1038671-2025-00398
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    May 24, 2018
    Report Date
    November 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2023-00662 D10 CONCOMITANT DEVICES: 1823218 204-32-01 - FLUTED STEM EXTENSION 11L X 12 MM. G4: 510K UNKNOWN DUE TO SPECIFIC DEVICE NOT BEING REPORTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-00662. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, D6A, H6. MDR SECTION CODES UPDATED/CORRECTED: A. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, DISLOCATION, AND LOSS OF RANGE OF MOTION OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INSTABILITY, DISLOCATION, AND LOSS OF RANGE OF MOTION OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 94 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, CHRONIC LEFT KNEE PAIN AND RECENT INCREASED LEFT KNEE PAIN, METAL RELATED PATHOLOGY, OSTEOLYSIS, SYNOVITIS, IMPLANT PAIN, SCAR TISSUE, JOINT LAXITY, LOSS OF RANGE OF MOTION IMPLANT. REVISION OPERATIVE REPORTS WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED FAILED LEFT KNEE REPLACEMENT. INTRAOPERATIVELY THE SURGEON NOTED THAT UPON ENTRY OF THE JOINT, EXTENSIVE GREY/BLACK SYNOVIUM WAS OBSERVED THROUGHOUT THE JOINT CONSISTENT WITH METALLOSIS REACTION. THE SURGEON NOTED THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED AND NOT LOOSE BUT OBSERVED EVIDENCE OF SEVERAL UNDERLYING AREAS OF OSTEOLYSIS ON BOTH COMPONENTS. THE PATELLAR BUTTON WAS NOTED TO HAVE SOME DELAMINATION OF THE POLYETHYLENE BUT MOSTLY INTACT WITH ONLY SLIGHT DEFORMATION AND IT WAS ELECTED TO RETAIN IT IN PLACE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. PATIENT WAS TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145250 OPTETRAK FEMORAL COMPONENT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Hospitalization| R SEE H11.