BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIPOLAR BIPOLAR CUP

    MDR report key: 3978761 · Received June 4, 2014

    Report

    Report Number
    2648920-2014-00145
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SPRING WAS STUCK AND NOT ABLE TO OPEN UP FOR THE SHELL TO BE PUSHED AND LOCKED ONTO THE LINER. THE SURGEON WAS UNABLE TO PUSH THE LINER ONTO THE SHELL AND HAD TO USE A DIFFERENT SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328079 MULTIPOLAR BIPOLAR CUP KWY ZIMMER MANUFACTURING B.V. 62618913

    Patients

    Seq Age Sex Outcome Treatment
    1