BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 11

    MDR report key: 1012977 · Received March 12, 2008

    Report

    Report Number
    1818910-2008-00721
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 13, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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

    THE BONE WAS FRACTURED DURING IMPACTION OF CORAIL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 NON COL HO SIZE 11 87KWA KWA DEPUY FRANCE S.A. NA 2498665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Disability