BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FIXED PS LINER SIZE 3, 10 MM

    MDR report key: 3787564 · Received April 16, 2014

    Report

    Report Number
    3005180920-2014-00042
    Event Type
    Injury
    Date Received
    April 16, 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 PS LINER SIZE 3, 10MM: REF. 02.07.0310PSF / LOT 121919 (60 LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. FIFTY SIX LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    REFERENCE IMPORTER REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233918 GMK FIXED PS LINER SIZE 3, 10 MM FIXED PS TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1