BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    MDR report key: 4221389 · Received November 3, 2014

    Report

    Report Number
    3010536692-2014-01550
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    January 15, 2010
    Report Date
    October 3, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 3010536692-2014-01548, 01549. THIS REPORT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS AND INFECTION OF HIP (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701599 PROFEMUR(R) Z STEM PLASMA SPRAYED HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. 056338879

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention