BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE FEMORAL COMPONENT SIZE 2 RIGHT

    MDR report key: 4217973 · Received July 29, 2014

    Report

    Report Number
    3005180920-2014-00097
    Event Type
    Injury
    Date Received
    July 29, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    GMK SPHERE CEMENTED FEMORAL COMPONENT - SIZE 2 RIGHT: CODE 02.12.0002R / LOT 131031 (B)(4): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. NINE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. GMK SPHERE FLEX PE FLEXED TIBIAL INSERT SIZE 2 RIGHT, 14 MM: CODE 02.12.0214FR / LOT 131516 (B)(4): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. FOUR ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. GMK PRIMARY FIXED CEMENTED TIBIAL TRAY SIZE 2 RIGHT: CODE 02.07.1202R / LOT 133423 (B)(4): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. TWENTY TWO ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE PROBLEM IS DEVICE RELATED BUT IT IS LIKELY RELATED TO A BAD POSITIONING OF THE IMPLANT DURING THE PRIMARY SURGERY.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442790 GMK SPHERE FEMORAL COMPONENT SIZE 2 RIGHT KNEE CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1