BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 1061664 · Received June 17, 2008

    Report

    Report Number
    1020279-2008-00180
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 17, 2008
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II TIBIAL COMPONENT HSH SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. NA 06LM15448

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R