BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 1071428 · Received July 8, 2008

    Report

    Report Number
    1020279-2008-00202
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 8, 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 THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION OF THE INSERT DURING REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II INSERT HSA SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. NA 04MM15336

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R