BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOURNEY

    MDR report key: 1153423 · Received July 11, 2008

    Report

    Report Number
    1153423
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 11, 2008
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    THE SMITH AND NEPHEW JOURNEY BRAND FEMORAL IMPACTOR, MODEL NUMBER: 7401-2811 HAS PEELING AND CHIPPING ISSUES FROM THE BLACK PLASTIC COATING OF THE CAM ARMS. THIS WAS BROUGHT TO THE ATTENTION OF THE OR BY THE MANAGER OF CSR. THIS ISSUE WAS DISCUSSED WITH THE SALES REPRESENTATIVE AND WITH THE OR STAFF. CONSENSUS WAS THAT THIS MAY BE RELATED TO DRIED CEMENT BEING CHIPPED OFF. THE SALES REP. FOR THIS DEVICE INDICATED THAT SMITH AND NEPHEW IS AWARE OF THIS ISSUE, AND HAVE HAD A FEW OTHER CASES REPORTED. THEY ARE CURRENTLY LOOKING FOR A MORE DURABLE PRODUCT THAT WILL NOT CHIP OFF. THE OR STAFF WAS ADVISED OF THE ISSUE/CONCERN AND WILL BE MINDFUL OF THE NEED TO CLEAN CEMENT OFF BEFORE IT HARDENS/DRIES. SMITH AND NEPHEW REPLACED BOTH OF THE ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY IMPACTOR, FEMORAL HWA SMITH & NEPHEW, INC. 7401-2811 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *