BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL 2 STD SIZE 8

    MDR report key: 1051135 · Received May 21, 2008

    Report

    Report Number
    1818910-2008-01869
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 7, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    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 PROD AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PROD AND/OR ADD'L INFO BE REC'D TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE-REOPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PROXIMAL LOOSENING OF THE FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL 2 STD SIZE 8 87KWA KWA DEPUY FRANCE S.A. NA 2138123

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention