BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOS GLENOID

    MDR report key: 1905496 · Received November 23, 2010

    Report

    Report Number
    9613369-2010-00067
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 23, 2010
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOOSENING MOVEMENT AND LOAD DEPENDENT PAIN IN THE RIGHT SHOULDER. SUSPECTED LOOSENING OF THE GLENOID COMPONENT IN (B)(6) 2009.REVISION ON (B)(6) 2009 WITH CHANGE OF THE HUMERAL HEAD AND THE GLENOID.IN CONTEXT OF A STUDY, WE BECAME AWARE OF THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOS GLENOID PROMOS GLENOID 1-23 CEMENTED HSD SMITH & NEPHEW, INC. 0204.13.2596

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention