BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER MIS TIBIAL COMPONENT

    MDR report key: 2141072 · Received June 21, 2011

    Report

    Report Number
    1822565-2011-01460
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    March 1, 2010
    Report Date
    May 23, 2011
    Manufacturer
    ZIMMER INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    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 FOR LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER MIS TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention