BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER NATL KNEE

    MDR report key: 1953697 · Received January 5, 2011

    Report

    Report Number
    MW5018895
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    September 11, 2009
    Report Date
    December 24, 2010
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE DEVICE SCREWS CAME OUT AND DEVICE DID PERMANENT DAMAGE THAT REQUIRED ANOTHER SURGERY 8 MONTHS LATER AND ANOTHER PRODUCT WAS PLACED IN KNEE. DAMAGE CAUSED ME UNABLE TO STAND OR WALK OVER 3 MINUTES. SWELLING, BLOOD CLOTS, 60% CLOSING OF MAIN BLOOD SUPPLY TO LEG. THIS HAS NOT BEEN TESTED BEFORE THEY PUT IN HUMANS. LAW SUITS ARE IN (B)(6) BECAUSE THEY COME APART, CAUSE DAMAGE AND TERRIBLE SECOND SURGERY IS NEEDED. XRAY MACHINES DON'T SEE ALL THE PROBLEM WHEN SCREWS COME OUT! SO PERSON SUFFERS FOR MONTHS! INSTEAD OF GETTING BETTER, YOU GET WORSE!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER NATL KNEE IMPLANT 65M FLX ART SURF LT 9 (LEFT) JWH ZIMMER 542801109 61142671
    2 ZIMMER NATL KNEE IMPLANT GSM FLX PATELLA SIZE 0 (LEFT) HTG ZIMMER 542000800 61204768
    3 ZIMMER NATL KNEE IMPLANT GSF KNEE FEMUR LT SIZE 2 (LEFT) JWH ZIMMER 541401501 61303131

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability