BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY FIXED CEMENTED FEMUR SIZE 5 LEFT

    MDR report key: 3242422 · Received July 18, 2013

    Report

    Report Number
    3006639916-2013-00084
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 18, 2013
    Manufacturer
    MEDACTA USA INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ALL THE IMPLANTS WERE REMOVED DUE TO INFECTION (STAPHILOCOCCUS AUREUS AND STREPTOCOCCUS GROUP B) 5 MONTHS POST OP. A KNEE SPACER WAS USED TO TREAT THE INFECTION. REF MFR NUMBER: 3005180920-2013-00084.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335333 GMK PRIMARY FIXED CEMENTED FEMUR SIZE 5 LEFT PS KNEE TIBIAL COMPONENT JWH MEDACTA USA INC. 103147

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention