BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) Z STEM

    MDR report key: 3250482 · Received July 26, 2013

    Report

    Report Number
    1043534-2013-01197
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    August 1, 2011
    Report Date
    June 25, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    PMA / PMN Number
    K021346
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED.(B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-01194, 01195, 01196.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT. RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349565 PROFEMUR(R) Z STEM HIP COMPONENT, CODE:LPH LPH WRIGHT MEDICAL TECHNOLOGY, INC. 016300044

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention