BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD

    MDR report key: 3241525 · Received July 22, 2013

    Report

    Report Number
    1043534-2013-01192
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 8, 2013
    Report Date
    July 17, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 INCIDENT AS 1043534-2013-01191. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT. ORIG. SURG. 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340976 FEMORAL HEAD HIP COMPONENT, CODE:MRA MRA WRIGHT MEDICAL TECHNOLOGY, INC. T10133577

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention