BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDER SOLUTIONS N-K FLEX ARTICULAR SURFACE

    MDR report key: 4222902 · Received August 6, 2014

    Report

    Report Number
    1822565-2014-00947
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 ARTICULAR SURFACE WOULD NOT SEAT PROPERLY ON THE MEDIAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459332 GENDER SOLUTIONS N-K FLEX ARTICULAR SURFACE MBH ZIMMER, INC. 62607733

    Patients

    Seq Age Sex Outcome Treatment
    1