BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SEGMENTAL DISTAL FEMORAL COMPONENT

    MDR report key: 3042098 · Received April 4, 2013

    Report

    Report Number
    1822565-2013-00602
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MIGRATED SCREW WAS EXPLANTED AND IS BEING RETURNED FOR EVALUATION. 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 THE GRUB SCREW BACKING OUT. ONLY THE GRUB SCREW FROM THE FEMORAL COMPONENT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138031 ZIMMER SEGMENTAL DISTAL FEMORAL COMPONENT KRO ZIMMER, INC. 61872518

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention