BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 1913294 · Received December 3, 2010

    Report

    Report Number
    1020279-2010-00339
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    December 2, 2010
    Manufacturer
    SMITH & NEPHEW, BROOKS MANUFACTURING SITE
    Product Code
    JWH
    Removal / Correction Number
    MW010
    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II FEMORAL COMPONENT JWH SMITH & NEPHEW, BROOKS MANUFACTURING SITE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R