BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) XM STEM

    MDR report key: 2223646 · Received August 25, 2011

    Report

    Report Number
    1043534-2011-00486
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    March 17, 2011
    Report Date
    September 29, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K052915
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    DEVICE #2: 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 1043534-2011-00485, 00487, 00488.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) XM STEM HIP COMPONENT KWA WRIGHT MEDICAL TECHNOLOGY, INC. W07337064

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R