BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NK FLEX ARTICULAR SURFACE PROVISIONAL

    MDR report key: 2081063 · Received April 14, 2011

    Report

    Report Number
    1822565-2011-00958
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 18, 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

    INFORMATION 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 PARTS BROKE OFF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NK FLEX ARTICULAR SURFACE PROVISIONAL JWH ZIMMER, INC. 61051564

    Patients

    Seq Age Sex Outcome Treatment
    1