BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) II TIBIAL BASE

    MDR report key: 3905453 · Received July 1, 2014

    Report

    Report Number
    3010536692-2014-00933
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    November 29, 2005
    Report Date
    June 2, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HRY
    PMA / PMN Number
    K960617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWS NO TREND FOR ITEM/LOT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. THE TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN ITALY. THIS IS THE SAME EVENT AS 3010536692-2014-00934.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO TOTAL ASEPTIC LOOSENING (LEFT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384989 ADVANCE(R) II TIBIAL BASE KNEE COMPONENT HRY MICROPORT ORTHOPEDICS INC. 02215768

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention