BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/DN FEMORAL/RECON NAIL

    MDR report key: 2843444 · Received November 15, 2012

    Report

    Report Number
    2648920-2012-00245
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    April 11, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ZIMMER
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO 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 A FRACTURE OF THE NAIL. IT IS REPORTED THAT THE PT EXPERIENCED A DIRECT TRAUMA WITH A CAR DOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M/DN FEMORAL/RECON NAIL HSB ZIMMER 60165698

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention