BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY FIXED TIBIAL INSERT SIZE 3 17MM

    MDR report key: 4297157 · Received November 14, 2014

    Report

    Report Number
    3005180920-2014-00156
    Event Type
    Injury
    Date Received
    November 14, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    GMK PRIMARY FIXED PE TIBIAL INSERT SIZE 3, 17 MM: CODE 02.07.0317SF/ LOT# 111418 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. THE (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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739036 GMK PRIMARY FIXED TIBIAL INSERT SIZE 3 17MM KNEE FIXED PE TIBIAL INSERT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1