BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    MDR report key: 3790065 · Received May 5, 2014

    Report

    Report Number
    3010536692-2014-00733
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    July 19, 2013
    Report Date
    April 30, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-00732. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO FRACTURE AT BASE OF THE MODULAR NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269418 PROFEMUR(R) Z STEM PLASMA SPRAYED HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. 106379844

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention