BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII CR

    MDR report key: 3103117 · Received May 9, 2013

    Report

    Report Number
    1020279-2013-00253
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    June 21, 2007
    Report Date
    April 17, 2013
    Manufacturer
    BROOKS MANUFACTURING SITE
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROBLEMS WITH LEFT KNEE GEN II LEFT TOTAL KNEE WITH 24-HOUR PAIN, INSTABILITY SINCE IMPLANTATION. AS TIME HAS GONE ON, IT HAS GOTTEN WORSE. DOCTOR DOES NOT WANT TO PERFORM A REVISION DUE TO OTHER EXISTING MEDICAL CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203036 GII CR GNS II C/R FEM SIZE 8 LEFT JWH BROOKS MANUFACTURING SITE 06JM05371

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other (B)(4)| (B)(4)