BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMULTIPOLAR BIPOLAR CUP LINER

    MDR report key: 3162367 · Received June 6, 2013

    Report

    Report Number
    2648920-2013-00127
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 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 LINER WOULD NOT SEAT IN THE SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251314 LMULTIPOLAR BIPOLAR CUP LINER KWY ZIMMER 62293261

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT #62138616| MULTIPOLAR BIPOLAR CUP SHELL, CATALOG #00500104500