BEUDAMED
    FDA Adverse Event Death Summary report: N

    GENESIS II

    MDR report key: 1186783 · Received October 6, 2008

    Report

    Report Number
    1020279-2008-00267
    Event Type
    Death
    Date Received
    October 6, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 3, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II TIBIAL BASE HSH SMITH & NEPHEW, INC., ORTHOPAEDIC DIV NA 06FM19112

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R