BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) Z STEM

    MDR report key: 3011564 · Received March 19, 2013

    Report

    Report Number
    1043534-2013-00563
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 14, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. PHOTOGRAPHIC IMAGES WERE MADE OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00561, 00562.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114592 PROFEMUR(R) Z STEM HIP COMPONENT, CODE:LPH LPH WRIGHT MEDICAL TECHNOLOGY, INC. U0366091

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention