BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) RENAISSANCE(R) STEM

    MDR report key: 3913804 · Received July 3, 2014

    Report

    Report Number
    3010536692-2014-00958
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 28, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY PT. FELL AND FRACTURED BONE. STEM SUBSIDED. MEDIUM ACTIVITY LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390006 PROFEMUR(R) RENAISSANCE(R) STEM HIP COMPONENT JDL MICROPORT ORTHOPEDICS INC. 1519035

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention