BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 11

    MDR report key: 1153230 · Received September 4, 2008

    Report

    Report Number
    1818910-2008-03483
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    June 29, 2008
    Report Date
    August 5, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    PT COMPLAINING OF SEVERE PAIN IN THE GROIN AREA WITH NO SIGNS OF CONTAMINATION. X-RAY SHOWS LOOSENING OF THE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 STD SIZE 11 87KWA KWA DEPUY INTERNATIONAL, LTD NA 1916342

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention