BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FEMUR STANDARD CEMENTED SIZE 5 RIGHT

    MDR report key: 3192561 · Received June 14, 2013

    Report

    Report Number
    3005180920-2013-00068
    Event Type
    Injury
    Date Received
    June 14, 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 5 RIGHT: CODE (B)(4)/LOT 102888 (9 TIME PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. EIGHT ITEMS BELONGING TO THIS LOT HAVE ALREADY BEEN IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. IT WAS REPORTED THAT "BAD CEMENT TO FEMUR INTERFACE FLEXED THE FEMORAL COMPONENT." ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCE THAT THE EVENT IS DEVICE RELATED, BUT IT CAN BE LIKELY RELATED TO A POOR CEMENTATION.

    Description of Event or Problem · 1

    REF IMP REPORT 3006639916-2013-00068.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272338 GMK FEMUR STANDARD CEMENTED SIZE 5 RIGHT KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1