BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) RAZ STEM

    MDR report key: 3687781 · Received March 19, 2014

    Report

    Report Number
    3010536692-2014-00497
    Event Type
    Injury
    Date Received
    March 19, 2014
    Date of Event
    March 2, 2014
    Report Date
    March 7, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 3010536692-2014-00496, 00498, 00499.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO BROKEN MODULAR NECK. PT WAS WALKING AND SLIPPED ON APPLE CORE AND FELL. PT FIRST THOUGHT IT WAS A DISLOCATION. X-RAYS AT ER SHOWED MODULAR NECK FRACTURE. DR (B)(6) WAS OUT OF TOWN. MEDIUM ACTIVITY LEVEL. WORKS IN FILM INDUSTRY AS A LIGHTING TECHNICIAN. BMI: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164384 PROFEMUR(R) RAZ STEM HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. PYRD-0005 077426984

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention