BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C/M INTERCHANGABLE HUMERAL ASSEMBLY

    MDR report key: 2013376 · Received March 8, 2011

    Report

    Report Number
    1822565-2011-00538
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE HUMERAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C/M INTERCHANGABLE HUMERAL ASSEMBLY JDC ZIMMER, INC. 61180180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention