BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY FIXED CEMENTED FEMUR SIZE 5 LEFT

    MDR report key: 3242438 · Received July 18, 2013

    Report

    Report Number
    3005180920-2013-00084
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY PS FEMUR COMPONENT SIZE 5 LEFT: CODE (B)(4) / LOT 103147 (13 ITEMS PRODUCED, 8 IMPLANTED UP TO NOW). GMK PRIMARY FIXED TIBIAL TRAY SIZE LEFT: CODE (B)(4), LOT 122602 (22 ITEMS PRODUCED, 13 IMPLANTED UP TO NOW). GMK PRIMARY FIXED PS LINER SIZE 4/14MM: CODE (B)(4), LOT 091290 (25 ITEMS PRODUCED, 11 IMPLANTED UP TO NOW). GMK PRIMARY CEMENTED STEM CODE (B)(4), LOT 121447(40 ITEMS PRODUCED, 26 IMPLANTED UP TO NOW). ALL PARAMETERS OF THE FOUR LOTS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG. THE WASHING CYCLES WERE RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATIONS. THE STERILIZATION CYCLES WERE PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMPORTER NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335430 GMK PRIMARY FIXED CEMENTED FEMUR SIZE 5 LEFT PS KNEE TIBIAL COMPONENT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1