BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIGLIANI/FLATOW GLENOID COMPONENT

    MDR report key: 6185538 · Received December 19, 2016

    Report

    Report Number
    0001822565-2016-04645
    Event Type
    Injury
    Date Received
    December 19, 2016
    Report Date
    December 14, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWT
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE "OUTCOMES AFTER SHOULDER REPLACEMENT: COMPARISON BETWEEN REVERSE AND ANATOMIC TOTAL SHOULDER ARTHROPLASTY¿. THE ARTICLE WAS WRITTEN BY TUYEN K. KIET, BRIAN T. FEELEY, MICAH NAIMARK, TATIANA GAJIU, SARAH L. HALL, TEDDY T. CHUNG AND C. BENJAMIN MA. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE DEVICE IS UNKNOWN. DEVICE HISTORY RECORDS CANNOT BE REVIEWED SINCE THE LOT NUMBER IS UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. PRODUCT HISTORY SEARCH CANNOT BE COMPLETED SINCE THE LOT NUMBER IS UNKNOWN. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT ONE PATIENT UNDERWENT SHOULDER ARTHROPLASTY REVISION DUE TO LOOSENING OF THE GLENOID COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837126 UNKNOWN BIGLIANI/FLATOW GLENOID COMPONENT SHOULDER PROSTHESIS KWT ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R