BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 LAT COXA VARA SIZE 12

    MDR report key: 751739 · Received August 14, 2006

    Report

    Report Number
    1818910-2006-02385
    Event Type
    Injury
    Date Received
    August 14, 2006
    Date of Event
    May 11, 2006
    Report Date
    July 26, 2006
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    NECK FRACTURE OF CORAIL STEM KLA 12 DURING PROFESSIONAL ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 LAT COXA VARA SIZE 12 TOTAL HIP REPLACEMENT KWY DEPUY FRANCE S.A. NA 1367231021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention