BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR FEMORAL STEM

    MDR report key: 2926391 · Received January 16, 2013

    Report

    Report Number
    1822565-2013-00099
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 17, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 PT WAS REVISED DUE TO THE STEM SUBSIDING. THE STEM SUBSIDED DUE TO A NON-UNITED OSTEOTOMY AND LATERAL FEMORAL BONE LOSS IN THE DISTAL AREA OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24457 ZMR FEMORAL STEM NONE KWY ZIMMER INC 60008582

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention