BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CRUCIAT RETAINING ARTICULAR SURFACE

    MDR report key: 4173547 · Received August 7, 2014

    Report

    Report Number
    1822565-2014-00959
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 IS REPORTED THAT THE SURGEON WAS UNABLE TO FULLY ENGAGE THE POLY INTO THE TIBIAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463115 NEXGEN CRUCIAT RETAINING ARTICULAR SURFACE JWH ZIMMER INC 62626331

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR