BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNASTY(R) BF SHELL

    MDR report key: 3973432 · Received August 1, 2014

    Report

    Report Number
    3010536692-2014-01060
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    January 26, 2011
    Report Date
    July 11, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS (B)(4). THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS (LEFT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451161 DYNASTY(R) BF SHELL HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 0201012354

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention