BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL-KNEE FLEX PROLONG ARTICULAR SURFACE

    MDR report key: 2093257 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01104
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 IT WAS IMPOSSIBLE TO SNAP THE INSERT INTO PLACE. A 2 MM THICKER INSERT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE FLEX PROLONG ARTICULAR SURFACE JWH ZIMMER INC 61069421

    Patients

    Seq Age Sex Outcome Treatment
    1