BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIPOLAR BIPOLAR LINER

    MDR report key: 3853480 · Received April 4, 2014

    Report

    Report Number
    2648920-2014-00078
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 8, 2014
    Manufacturer
    ZIMMER
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 LINER WOULD NOT SEAT CORRECTLY IN THE SHELL. A NEW LINER AND SHELL WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203571 MULTIPOLAR BIPOLAR LINER KWY ZIMMER 62293255

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR CATALOG #00500104200, LOT #62467596| MULTIPOLAR BIPOLAR SHELL: