BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAMER SLR BIPOLAR ACETABULAR SHELL LINER

    MDR report key: 1021988 · Received March 28, 2008

    Report

    Report Number
    1043534-2008-00052
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 13, 2008
    Report Date
    March 6, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWB
    PMA / PMN Number
    K861566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN REC'D FROM THE USER FACILITY. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETED. THIS IS THE SAME EVENT AS 1043534-2008-00051.

    Description of Event or Problem · 1

    ALLEGEDLY BIPOLAR ACETABULAR LINER COMPONENT BROKE IN-SITU. PT WAS HAVING PAIN IN HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMER SLR BIPOLAR ACETABULAR SHELL LINER NONE KWB WRIGHT MEDICAL TECHNOLOGY, INC. 057A063194

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R