BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 LAT COXA VARA SIZE 11

    MDR report key: 785936 · Received November 16, 2006

    Report

    Report Number
    1818910-2006-03578
    Event Type
    Injury
    Date Received
    November 16, 2006
    Date of Event
    October 15, 2006
    Report Date
    October 18, 2006
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    LPH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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 2002. A RECALL WAS CONDUCTED 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 APRIL 2005. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO FEMORAL NECK FRACTURE OF CORAIL STEM KLA 11. THE PATIENT WAS WALKING AND FELL AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 LAT COXA VARA SIZE 11 TOTAL HIP REPLACEMENT LPH DEPUY FRANCE S.A. NA 1278550

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention