BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 12

    MDR report key: 1250692 · Received December 2, 2008

    Report

    Report Number
    1818910-2008-05690
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 5, 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
    AS
    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

    REVISION SURGERY DUE TO LOOSENING OF THE FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 NON COL HO SIZE 12 87KWA KWA DEPUY FRANCE S.A. NA 1870304

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention