BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAILS2 STD SIZE 10

    MDR report key: 1192015 · Received October 6, 2008

    Report

    Report Number
    1818910-2008-04341
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED N THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF A FRACTURED FEMUR AND STEM WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAILS2 STD SIZE 10 87KWA KWA DEPUY FRANCE S. A. NA 2515492

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention