BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1043534-2012-01250

    MDR report key: 2769186 · Received October 2, 2012

    Report

    Report Number
    1043534-2012-01250
    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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REOPENED TO FILE REPORTABLE MALFUNCTION MDR BASED ON RISK ASSESSMENT REF #(B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY PRODUCT HAS AN EXPIRATION DATE ON THE BOX OF 02/09, BUT WAS SHOWING EXPIRED IN 2012 IN (B)(6).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1