BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE

    MDR report key: 3912451 · Received May 14, 2014

    Report

    Report Number
    1822565-2014-00618
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 SURGEON WAS UNABLE TO PROPERLY SEAT THE ARTICULAR SURFACE. ANOTHER SURFACE WAS OPENED AND USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288376 NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE JWH ZIMMER, INC. 62544033

    Patients

    Seq Age Sex Outcome Treatment
    1