BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FEMUR STANDARD CEMENTED SIZE 4 RIGHT

    MDR report key: 3253972 · Received July 23, 2013

    Report

    Report Number
    3005180920-2013-00088
    Event Type
    Injury
    Date Received
    July 23, 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 STANDARD FEMUR COMPONENT SIZE 4 RIGHT: CODE (B)(4) / LOT 102994 (25 ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE 21 ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. GMK PRIMARY FIXED UC TIBIAL INSERT SIZE 4 THICKNESS 12: CODE (B)(4) / LOT 103157 (25 ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE 23 ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    PLEASE REFER IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342237 GMK FEMUR STANDARD CEMENTED SIZE 4 RIGHT KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1