BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN ALL POLY PATELLA

    MDR report key: 1970929 · Received January 5, 2011

    Report

    Report Number
    1822565-2011-00015
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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 FEELS THAT THE PACKAGING IS INADEQUATELY SEALED WHICH COULD POSSIBLY COMPROMISE THE STERILITY OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN ALL POLY PATELLA KNEE PROSTHESIS JWH ZIMMER INC 61618537

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT# UNK| CATALOG# UNK| UNKNOWN ZIMMER POLY PATELLA, DEVICE