BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD

    MDR report key: 1860903 · Received October 7, 2010

    Report

    Report Number
    1043534-2010-00405
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    August 21, 2010
    Report Date
    May 2, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K004043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00404. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. DEVICE HISTORY RECORD REVIEWED. EVIDENCE THAT PRODUCT IN SPEC WHEN USED. DEVICE USED ACCORDING TO LABEL INDICATIONS.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT WAS REVISED DUE TO DISLOCATION.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD HIP COMPONENT JDL WRIGHT MEDICAL TECHNOLOGY, INC. 089912891

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R