BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT STEM KLA13

    MDR report key: 1822679 · Received August 27, 2010

    Report

    Report Number
    1818910-2010-06340
    Event Type
    Injury
    Date Received
    August 27, 2010
    Report Date
    August 25, 2010
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE REPORTED PRODUCT/LOT NUMBER WAS PART OF A BATCH OF PRODUCTS WHICH WERE SUSCEPTIBLE TO FRACTURE. THE ETCH LOCATION WAS CHANGED BY A DESIGN REVISION IN (B)(6) 2002. A RECALL WAS CONDUCTED, IN (B)(6), TO REMOVE ALL AFFECTED PRODUCTS FROM THE MARKET. NOTE - AFFECTED PRODUCT WAS NOT DISTRIBUTED IN THE US., AS US DISTRIBUTION DID NOT BEGIN UNTIL APRIL 2005. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    NECK FRACTURE OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL AMT STEM KLA13 87KWA KWA DEPUY FRANCE, S.A. A 1367233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention