BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL STEM K14S HAC

    MDR report key: 1035947 · Received April 29, 2008

    Report

    Report Number
    1818910-2008-01672
    Event Type
    Injury
    Date Received
    April 29, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FRACTURE AT THE ETCH LOCATION WAS CONFIRMED. THE ETCH LOCATION WAS CHANGED BY A DESIGN REVISION IN LATE 2002. A RECALL WAS CONDUCTED, IN ANOTHER COUNTRY, TO REMOVE ALL ATTACHED PRODUCTS FROM THE MARKET. NOTE - AFFECTED PRODUCT WAS NOT DISTRIBUTED IN THE U.S., AS U.S. DISTRIBUTION DID NOT BEGIN UNTIL APRIL 2005.

    Description of Event or Problem · 1

    FRACTURE OF CORAIL WHEN THE PATIENT STOOD UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL STEM K14S HAC 87KWA KWA DEPUY FRANCE S.A. NA 395184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention