BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1043534-2012-01181

    MDR report key: 2754867 · Received September 21, 2012

    Report

    Report Number
    1043534-2012-01181
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Report Date
    September 19, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LWJ
    PMA / PMN Number
    P030027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER FDA, REOPENED FILE AS A REPORTABLE MALFUNCTION IN ORDER TO REPORT AS PART OF A RETROSPECTIVE REVIEW OF CERAMIC HEADS. THIS IS THE SAME EVENT AS 1043534-2012-01180, 01182, 01183, 01184.

    Description of Event or Problem · 1

    ALLEGEDLY HIP WILL "GIVE WAY" AND PATIENT FALLS. SURGEON ADVISED THERE IS NOTHING WRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LWJ WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR