BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN PROLONG CR ARTICULAR SURFACE

    MDR report key: 2781958 · Received October 5, 2012

    Report

    Report Number
    1822565-2012-02031
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. 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 PROPERLY INSERT THE ARTICULAR SURFACE. THE SURGERY WAS THEN COMPLETED WITH A LARGER ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN PROLONG CR ARTICULAR SURFACE JWH ZIMMER, INC. 61977204

    Patients

    Seq Age Sex Outcome Treatment
    1