BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CR ARTICULAR SURFACE

    MDR report key: 2852758 · Received November 14, 2012

    Report

    Report Number
    1822565-2012-02337
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 ARTICULAR SURFACE COULD NOT BE SEATED DURING KNEE SURGERY. A NEW IMPLANT WAS OPENED AND WENT ON EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR ARTICULAR SURFACE JWH ZIMMER, INC. 62029355

    Patients

    Seq Age Sex Outcome Treatment
    1