BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI ECCENTER-STERILE

    MDR report key: 3606102 · Received February 4, 2014

    Report

    Report Number
    1719045-2014-00038
    Event Type
    Injury
    Date Received
    February 4, 2014
    Report Date
    January 7, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWT
    PMA / PMN Number
    K072578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS INTENDED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). ADDITIONAL PRODUCT CODES INCLUDE MBF, HSD. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED FOR EVALUATION. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY AND HARDWARE EXPLANT OF AN EPOCA SHOULDER ARTHROPLASTY SYSTEM WAS PERFORMED DUE TO NONUNION OF THE PATIENTS GREATER TUBEROSITY, LIMITED EXTERNAL ROTATION AND INABILITY TO LIFT THE IMPLANTED ARM PAST 30 DEGREES. THE SURGEON ORIGINALLY PERFORMED A HEMIARTHROPLASTY OF THE SHOULDER AND IMPLANTED THE PATIENT WITH THE EPCOA SHOULDER ARTHROPLASTY SYSTEM ON (B)(6) 2013. DURING A POST-OPERATIVE EXAM IN EARLY (B)(6), THE PATIENT PRESENTED WITH LIMITED EXTERNAL ROTATION AND THE INABILITY TO LIFT THE IMPLANTED ARM PAST 30 DEGREES. IMAGING WAS PERFORMED, AND THE PATIENT WAS DIAGNOSED WITH NONUNION OF THE GREATER TUBEROSITY OF THE HUMERUS AND WAS DIAGNOSED WITH CUFF TEAR ARTHROPATHY. THE PATIENT WAS REVISED TO A REVERSE TOTAL SHOULDER SYSTEM (MANUFACTURER UNKNOWN) ON (B)(6) 2014. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE REVISION WAS REPORTEDLY NOT DUE TO A DEVICE RELATED ISSUE CONCERNING THE EPOCA SHOULDER ARTHROPLASTY SYSTEM PRODUCTS. THIS IS REPORT 3 OF 5 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73142 TI ECCENTER-STERILE KWT SYNTHES MONUMENT 6766644

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention