BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AESCULAP VEGA

    MDR report key: 7979402 · Received October 17, 2018

    Report

    Report Number
    MW5080668
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    July 16, 2018
    Manufacturer
    B. BRAUN / AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMPLANT LOOSENING 18 MONTHS POST IMPLANTATION. FEMUR FLANGE LOOSENING. ASEPTIC FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813741 AESCULAP VEGA KNEE REPLACEMENT JWH B. BRAUN / AESCULAP IMPLANT SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention