BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIPOLAR BIPOLAR SHELL

    MDR report key: 3151341 · Received May 30, 2013

    Report

    Report Number
    2648920-2013-00122
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ZIMMER
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE LOCKING RING WAS STUCK IN THE GROOVE. A DIFFERENT SHELL WAS OPENED AND IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237635 MULTIPOLAR BIPOLAR SHELL KWY ZIMMER 62154588

    Patients

    Seq Age Sex Outcome Treatment
    1