BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 1033791 · Received April 25, 2008

    Report

    Report Number
    1020279-2008-00134
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    January 2, 2007
    Report Date
    April 25, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
    Product Code
    HSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY OUR LEGAL DEPARTMENT THAT REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II FEMORAL COMPONENT HSA SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. NA 90609366

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R