BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY CORAIL STEM

    MDR report key: 2252576 · Received September 18, 2011

    Report

    Report Number
    1818910-2011-17062
    Event Type
    Injury
    Date Received
    September 18, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 30, 2011
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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 OF CORAIL STEM THE MEDICAL REASON FOR BEING REVISED WAS A FAILED ASR CUP AND THE STEM HAD COME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY CORAIL STEM FEMORAL HIP STEM KWA DEPUY FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention