BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO MODEL

    MDR report key: 21394793 · Received February 18, 2025

    Report

    Report Number
    3004371426-2025-00008
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    December 11, 2024
    Report Date
    January 25, 2025
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    UDI-DI
    04026575316755
    PMA / PMN Number
    K143179
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE HISTRORY RECORD SHOWED NO DEVIATIONS. THIS IS THE FINAL SUPPLEMENTAL REPORT. THE COMPLAINT IS CLOSED.

    Description of Event or Problem · 0

    THE FEMORAL IMPLANT STOP MADE OF PE WAS MISSING. ANOTHER IMPLANT HAD TO BE OPENED. ISSUE WAS NOTICED BEFORE IMPLANTATION. THE IMPLANT WAS THEREFORE NOT USED. [CUSTOMER].

    Description of Event or Problem · 0

    THE FEMORAL IMPLANT STOP MADE OF PE WAS MISSING. ANOTHER IMPLANT HAD TO BE OPENED. ISSUE WAS NOTICED BEFORE IMPLANTATION. THE IMPLANT WAS THEREFORE NOT USED. [CUSTOMER].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489754 ENDO MODEL TOTAL HINGE KNEE TIBIAL COMPONENT, NEUTRAL, MEDIUM COCRMO, WITH GROOVES KRO WALDEMAR LINK GMBH & CO. KG 15-2834/03 04026575316755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention