BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT

    MDR report key: 2894256 · Received December 21, 2012

    Report

    Report Number
    3005180920-2012-00096
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 21, 2012
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY CEMENTED FIXED TIBIAL TRAY SIZE 3 RIGHT: CODE 02.07.1203R / LOT 102460 (36 ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. TWENTY-FIVE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. MEDACTA REQUESTED THE ANALYSIS OF THE X-RAYS TO AN EXPERT CONSULTANT: HE SAW THAT THERE WAS EXTREMELY FEW CEMENT AT THE TIBIA WHILE THE THICKNESS OF CEMENT SHOULD BE AROUND 2 MM. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IN THE EVENT OCCURRED IS HIGHLY UNLIKELY, BUT CAN BE LIKELY DUE TO A WRONG TECHNIQUE OF CEMENTATION.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO LOOSENING OF THE CEMENTED TIBIAL TRAY 24 MONTHS POST OP, THE PATIENT FELL ONTO HIS KNEE DURING A BUS RIDE. IT WAS REPORTED THAT THE TIBIA WAS FOUND NOT TO BE INTEGRATED INTO CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMK TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT KNEE TIBIAL COMPONENT JWH MEDACTA INTERNATIONAL SA 102460

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention