BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 17449796 · Received August 3, 2023

    Report

    Report Number
    1038671-2023-01850
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    April 10, 2023
    Report Date
    January 9, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, TIBIAL LOOSENING, AND FEMORAL LOOSENING. 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. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2016. APPROXIMATELY 6 YEARS AND 4 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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 IS AVAILABLE.REVISION OP REPORT ON 10 APR 2023DIAGNOSIS: LOOSENING OF PROSTHESIS OF TOTAL RIGHT KNEE REPLACEMENTTHE PATELLAR BUTTON WAS FOUND TO BE INTACT BUT WITH SOME SURFACE WEAR. THE FEMUR - COULD EASILY TAMP OFF THE FEMORAL COMPONENT WHICH WAS NOTED TO HAVE COMPLETELY DEBONDED FROM ITS CEMENT MANTLE. THERE WAS NOTED TO BE AORI TYPE I BONE LOSS, MILD OSTEOLYSIS AFFECTING BOTH MEDIAL AND LATERAL CONDYLES. THE TIBIA - TIBIAL COMPONENT WAS FOUND TO BE LOOSE. BONY INVENTORY AFTER REMOVAL CEMENT OF THE TIBIA REVEALED TYPE I BONE LOSS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699653 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown Required Intervention