BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS NOETOS FEMORAL IMPLANT WITH HA

    MDR report key: 2322010 · Received October 18, 2011

    Report

    Report Number
    9610667-2011-00022
    Event Type
    Malfunction
    Date Received
    October 18, 2011
    Date of Event
    March 12, 2009
    Report Date
    July 3, 2009
    Manufacturer
    TORNIER INC.
    Product Code
    JWH
    PMA / PMN Number
    K013906
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED. RADIOGRAPHS WERE NOT USABLE. NO ADDITIONAL INFO WAS MADE AVAILABLE AFTER MULTIPLE REQUESTS. TORNIER INC. IS SUBMITTING THIS MEDICAL DEVICE REPORT AS A RESULT OF A PROACTIVE REVIEW OF VIGILANCE EVENTS REPORTED TO THE (B)(4) OR TO OTHER COMPETENT AUTHORITIES IN THE EUROPEAN UNION DURING 2009 AND 2010. THE EVENTS DESCRIBED IN THIS MEDICAL DEVICE REPORT OCCURRED OUTSIDE OF THE UNITED STATES. THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE INFO CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS REGARDING MEDICAL DEVICE REPORTING AND IS BASED ON INFO SUBMITTED BY OTHERS THAT MAY OR MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTION OR IS RELATED TO A DEATH OR INJURY.

    Description of Event or Problem · 1

    LOOSENING OF THE TIBIAL BASE WAS NOTICED AT FIVE-MONTHS POST-OPERATIVE. REVISION SURGERY REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HLS NOETOS FEMORAL IMPLANT WITH HA FEMORAL IMPLANT JWH TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention