BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIPOLAR BIPOLAR CUP SHELL

    MDR report key: 2193587 · Received July 14, 2011

    Report

    Report Number
    2648920-2011-00036
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 16, 2011
    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 WAS REPORTED THAT THE LOCKING RING ON 44MM CUP DID NOT MOVE FREELY AFTER THE INSERTION OF LINER. THE SURGEON THEN ATTEMPTED TO IMPLANT 43MM COMPONENTS BUT WAS UNSUCCESSFUL. SURGERY WAS COMPLETED WITH A 45MM CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIPOLAR BIPOLAR CUP SHELL KWY ZIMMER 61692032

    Patients

    Seq Age Sex Outcome Treatment
    1