BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROFEMUR(R) XM STEM

    MDR report key: 4033259 · Received August 25, 2014

    Report

    Report Number
    3010536692-2014-01221
    Event Type
    Death
    Date Received
    August 25, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-01219, -01220. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS (LEFT). THE PATIENT DECOMPENSATED RIGHT AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511357 PROFEMUR(R) XM STEM HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. W07337066

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death