BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN RHK ARTICULAR SURFACE PROVISIONAL

    MDR report key: 2193414 · Received July 13, 2011

    Report

    Report Number
    1822565-2011-01643
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ARTICULAR SURFACE PROVISIONAL FRACTURED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN RHK ARTICULAR SURFACE PROVISIONAL JWH ZIMMER INC 60248279

    Patients

    Seq Age Sex Outcome Treatment
    1