BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TIBIAL TRAY SIZE T3I4 RIGHT

    MDR report key: 4173721 · Received September 25, 2014

    Report

    Report Number
    3005180920-2014-00127
    Event Type
    Injury
    Date Received
    September 25, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    GMK SPHERE CEMENTED FIXED TIBIAL TRAY SIZE T3I4 RIGHT: CODE 02.12.T3I4R / LOT 113551 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG. (B)(4) 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 EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    IMP REF #(B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596668 GMK SPHERE TIBIAL TRAY SIZE T3I4 RIGHT KNEE FIXED CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1