BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) RAZ STEM

    MDR report key: 2830899 · Received November 13, 2012

    Report

    Report Number
    1043534-2012-01530
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    February 3, 2009
    Report Date
    October 16, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REVEALED THIS COMPONENT WAS NOT REMOVED DURING THE REVISION SURGERY AND, THEREFORE, SHOULD NOT HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    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 1043534-2012-01527, 01528, 01529.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO METAL ON METAL COMPLICATIONS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) RAZ STEM HIP COMPONENT, CODE:LPH LPH WRIGHT MEDICAL TECHNOLOGY, INC. 108634882

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention