BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATITUDE TOTAL ELBOW PROSTHESIS

    MDR report key: 5065165 · Received September 9, 2015

    Report

    Report Number
    3004983210-2015-00035
    Event Type
    Injury
    Date Received
    September 9, 2015
    Report Date
    November 20, 2015
    Manufacturer
    TORNIER, INC
    Product Code
    JDB
    PMA / PMN Number
    K100562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    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

    FIFTY-EIGHT PATIENTS UNDERWENT LATITUDE TOTAL ELBOW REPLACEMENT. OF THE 58 PATIENTS 6 PATIENTS REQUIRED REVISION SURGERY. THREE OF THE 6 REVISIONS WERE DUE TO INFECTION. ARTICLE: EARLY RESULTS OF LATITUDE PRIMARY TOTAL ELBOW REPLACEMENT WITH A MINIMUM FOLLOW UP OF TWO YEARS, AUTHORS: SAURABH MEHTA, ANN BIRCH, PROF A WATTS, PROF IAN TRAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596462 LATITUDE TOTAL ELBOW PROSTHESIS ELBOW PROSTHESIS JDB TORNIER, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other