BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) RAZ STEM

    MDR report key: 3592596 · Received January 27, 2014

    Report

    Report Number
    3010536692-2014-00027
    Event Type
    Injury
    Date Received
    January 27, 2014
    Date of Event
    November 12, 2012
    Report Date
    January 13, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. (B)(6). TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-00024, -00025, -00026. THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO MOM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58935 PROFEMUR(R) RAZ STEM HIP COMPONENT, CODE:LPH LPH MICROPORT ORTHOPEDICS INC. 026284375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention