BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER MILLER GALANTE ARTICULAR SURFACE

    MDR report key: 2000995 · Received February 21, 2011

    Report

    Report Number
    1822565-2011-00358
    Event Type
    Injury
    Date Received
    February 21, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO THE ARTICULAR SURFACE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER MILLER GALANTE ARTICULAR SURFACE HSX ZIMMER INC 60235774

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention