BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LATITUDE TOTAL ELBOW SYSTEM

    MDR report key: 5015698 · Received August 19, 2015

    Report

    Report Number
    3004983210-2015-00029
    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. 3 (4%) OF THE PATIENTS EXPERIENCED FRACTURES. ONE OF THE ULNAR FRACTURES WAS IDENTIFIED PERI-OPERATIVELY AND WAS TREATED WITH CERCLAGE WIRE, WITH SUBSEQUENT SATISFACTORY UNION. THE OTHER WAS NOTED POST OPERATIVELY AND WAS MANAGED CONSERVATIVELY AND HEALED UNREMARKABLY. ONE OF THE HUMERAL FRACTURES INVOLVED THE MEDIAL EPICONDYLE AND WAS FIXED WITH A KIRSHNER WIRE AND HEALED SATISFACTORILY. ARTICLE CITATION: BONE JOINT J 2015; 97-B:681-8. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549957 LATITUDE TOTAL ELBOW SYSTEM ELBOW PROSTHESIS JDB TORNIER, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention