BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) TL STEM

    MDR report key: 3922332 · Received July 9, 2014

    Report

    Report Number
    3010536692-2014-00976
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    July 8, 2013
    Report Date
    June 12, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-00972, -00973, 00974, 00975. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO DISLOCATION (LEFT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399258 PROFEMUR(R) TL STEM HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 039808855

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention