BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD

    MDR report key: 923615 · Received October 4, 2007

    Report

    Report Number
    1043534-2007-00162
    Event Type
    Injury
    Date Received
    October 4, 2007
    Date of Event
    September 7, 2007
    Report Date
    September 25, 2007
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K004043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS IS THE SAME EVENT AS 1043534-2007-00161, 00163.

    Description of Event or Problem · 1

    ALLEGEDLY, RECURRENT DISLOCATION. COMPONENT POSITION LOOKED UNCHANGED ON X-RAY. ON OPENING THE HIP, QUITE SEVERE METALLOSIS WAS FOUND. DECIDED TO REMOVE THE TRANSCEND CUP AND INSERTED A LINEAGE SHELL, CHANGING THE ORIENTATION SLIGHTLY. INSERTED A 15 DEG LATERALIZED +4MM LINER AND NSF 32MM +7MM HEAD TO ET SUITABLE STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD JDL WRIGHT MEDICAL TECHNOLOGY, INC. 084100343

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R