BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1043534-2012-01251

    MDR report key: 2769187 · Received October 2, 2012

    Report

    Report Number
    1043534-2012-01251
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Report Date
    September 5, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JWH
    PMA / PMN Number
    K111699
    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 ASSESMENT REF #(B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY JDE LISTS THE EXPIRATION DATE FOR THIS LOT AS 11/24/2011, BUT THE LABEL ON THE BOX LISTS IT AS 2008-10.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1