BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1043534-2012-01253

    MDR report key: 2769188 · Received October 2, 2012

    Report

    Report Number
    1043534-2012-01253
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Report Date
    September 5, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LWJ
    PMA / PMN Number
    K003016
    Removal / Correction Number
    R12060002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REOPENED TO FILE REPORTABLE MALFUNCTION MDR BASED ON RISK ASSESSMENT (B)(4). THIS IS THE SAME EVENT AS 1043534-2012-01254, 01255, 01256, 01257, 01258, 01259.

    Description of Event or Problem · 1

    ALLEGEDLY THESE BOXES ALL HAVE EXPIRATION DATES ON THEM THAT DO NOT MATCH THE EXPIRATION DATES IN THE JDE LOT MASTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1