BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FIXED PS TIBIAL INSERT SIZE 2 / 14 MM

    MDR report key: 3676475 · Received February 26, 2014

    Report

    Report Number
    3005180920-2014-00016
    Event Type
    Injury
    Date Received
    February 26, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY FIXED TIBIAL INSERT SIZE 2 / 14MM. CODE 02.07.0214PSF / LOT 111378 (30 ITEMS PRODUCED) : ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. (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 PROBLEM 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
    117422 GMK FIXED PS TIBIAL INSERT SIZE 2 / 14 MM PS FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1