BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDER SOLUTIONS NATURAL KNEE FLEX SYSTEM

    MDR report key: 1202043 · Received October 16, 2008

    Report

    Report Number
    MW5008609
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ZIMMER KNEE IMPLANTS WERE DAMAGED DURING INSERTION ON TWO SEPARATE DAYS, TWO SEPARATE PTS, BY TWO SEPARATE PHYSICIANS. COMPANY REP WAS PRESENT ON BOTH OCCASIONS TO ENSURE APPROPRIATE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDER SOLUTIONS NATURAL KNEE FLEX SYSTEM KNEE IMPLANTS JWH ZIMMER

    Patients

    Seq Age Sex Outcome Treatment
    1