BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL IMPLANT IMPACTOR

    MDR report key: 2853362 · Received November 30, 2012

    Report

    Report Number
    1020279-2012-00647
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS RETURNED AND EVALUATED. OUR INVESTIGATION CONFIRMED THE FAILURE MODE OF THE DEVICE. THIS FAILURE HAS BEEN COMMUNICATED TO CAPA TEAM FOR CONSIDERATION OF APPROPRIATE CORRECTIONS/ CORRECTIVE ACTIONS. SUPPLIER CORRECTIVE ACTIONS WERE COMPLETED IN (B)(4) 2012. NO COMPLAINTS HAVE BEEN RECEIVED FOR DEVICES MANUFACTURED AFTER THE IMPLEMENTATION OF THOSE CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ADDITIONAL SURGERY WAS PERFORMED IN ORDER TO REMOVE A FRACTURED PORTION OF THE INSTRUMENTATION USED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL IMPLANT IMPACTOR FEMORAL IMPLANT IMPACTOR JWH SMITH & NEPHEW, INC. 10LM12286

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R