BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LATITUDE TOTAL ELBOW SYSTEM

    MDR report key: 5015203 · Received August 19, 2015

    Report

    Report Number
    3004983210-2015-00019
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Report Date
    November 20, 2015
    Manufacturer
    TORNIER, INC.
    Product Code
    JDB
    PMA / PMN Number
    K100562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    BETWEEN 2006 AND 2008 A TOTAL OF 19 MEN AND 50 WOMEN UNDERWENT TEA (TOTAL ELBOW ARTHROPLASTY) SURGERY. 13 (31%) OF THE PATIENTS EXPERIENCED DISENGAGEMENT OF THE RADIAL HEAD COMPONENT WITH A RADIAL HEAD COMPONENT IMPLANTED. ARTICLE CITATION: BONE JOINT J 2015; 97-B:681-8. RADIAL HEAD (RH) DISENGAGEMENT MAY BE DUE TO THE SURGICAL TECHNIQUE WITH A HIGH PLACEMENT. THE RH MAY HAVE BEEN IMPLANTED TOO HIGH AS THERE IS NO GUIDE IN THE LATITUDE LEGACY INSTRUMENT SET; THUS, THE SURGEON, DR. (B)64) BELIEVES THAT THERE IS A POSSIBILITY OF OVER STUFFING AND THUS LEADING TO THE DISLOCATION OF THE HEAD AND THE STEM. ACCORDING TO DR. (B)(6) THE RESULTS OF THIS ARTICLE ARE ONLY BASED ON THE LATITUDE SYSTEM AND NOT LATITUDE EV. DR. (B)(6) STATED THAT ALL CASES WERE ASYMPTOMATIC AND NO CASES WERE REVISED BECAUSE OF THE RH. ONLY ONE RH CASE WAS REVISED, BUT ONLY TO LINK THE PROSTHESIS, THERE WAS NO RELATION TO THE RH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549985 LATITUDE TOTAL ELBOW SYSTEM ELBOW PROSTHESIS JDB TORNIER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention