BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT STEM KLA SZ 16

    MDR report key: 1905525 · Received November 19, 2010

    Report

    Report Number
    1818910-2010-08881
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 24, 2010
    Report Date
    November 4, 2010
    Manufacturer
    DEPUY FRANCA 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 SUSPECTABLE TO FRACTURE. THE ETCH LOCATION WAS CHANGED BY A DESIGN REVISION IN (B)(6) 2002. A RECALL WAS CONDUCTED, IN (B)(4), TO REMOVE ALL AFFECTED PRODUCTS FROM THE MARKET. NOTE - AFFECTED PRODUCT WAS NOT DISTRIBUTED IN THE U.S., AS U.S. DISTRIBUTION DID NOT BEGIN UNTIL (B)(6) 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 CORAIL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL AMT STEM KLA SZ 16 87KWA KWA DEPUY FRANCA S.A. NA 1282846

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention