BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1003185 · Received February 22, 2008

    Report

    Report Number
    1003185
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    July 18, 2007
    Report Date
    February 20, 2008
    Manufacturer
    UNK
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PREVIOUS RIGHT TOTAL KNEE PROSTHESIS, INSERTED 2005, CAUSING PAIN AND SWELLING WAS REMOVED AND REPLACED. UPON EXPOSURE, MALROTATION OF THE FEMORAL COMPONENT AND VARUS POSITIONING OF THE TIBIAL COMPONENT WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK KNEE REPLACEMENT JWH UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention