BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD

    MDR report key: 1960455 · Received January 13, 2011

    Report

    Report Number
    1043534-2011-00004
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 17, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    PMA / PMN Number
    K002149
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    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 1043534-2011-00002, 00003.

    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
    1 LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD HIP COMPONENT LPH WRIGHT MEDICAL TECHNOLOGY, INC. 04479180

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R