BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FIXED CEMENTED TIBIAL TRAY

    MDR report key: 3519927 · Received November 22, 2013

    Report

    Report Number
    3005180920-2013-00146
    Event Type
    Injury
    Date Received
    November 22, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK FIXED CEMENTED TIBIAL TRAY SIZE 3 RIGHT. CODE (B)(4) / LOT 100866 (34 ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. ALL THE 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 NOT PROPER CEMENTATION TECHNIQUE DURING THE PRIMARY SURGERY.

    Description of Event or Problem · 1

    REFERENCE IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609372 GMK FIXED CEMENTED TIBIAL TRAY CEMENTED TIBIAL BASE PLATE JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1