BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATITUDE

    MDR report key: 5196726 · Received November 2, 2015

    Report

    Report Number
    3004983210-2015-00050
    Event Type
    Injury
    Date Received
    November 2, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 29, 2015
    Manufacturer
    TORNIER INC.
    Product Code
    JDB
    PMA / PMN Number
    K100562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS REGARDING MEDICAL DEVICE REPORTING AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY OR MAY NOT BE FACTUALLY CORRECT.

    Description of Event or Problem · 1

    FAILED RIGHT TOTAL ELBOW ARTHROPLASTY WITH LOOSE HUMERAL COMPONENT AND DISASSEMBLED LINKAGE MECHANISM. RESTORE FUNCTION. REVISION RIGHT TOTAL ELBOW ARTHROPLASTY, REMOVAL OF LOOSE COMPONENTS. REMOVED IMPLANTS WERE REPLACED WITH LATITUDE ULNAR CAP DKY069, LATITUDE SPOOL DKY215, LATITUDE HUMERAL STEM 0030502, LATITUDE ULNAR BUSHING DKY122.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724856 LATITUDE ULNAR STEM, STANDARD LARGE RIGHT JDB TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention ANTERIOR OFFSET SPOOL LARGE RIGHT