BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL STEM K14S HAC

    MDR report key: 1488281 · Received September 29, 2009

    Report

    Report Number
    1818910-2009-05465
    Event Type
    Injury
    Date Received
    September 29, 2009
    Report Date
    August 30, 2009
    Manufacturer
    DEPUY FRANCE S. A.
    Product Code
    LZO
    PMA / PMN Number
    K953111
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CORAIL SHAFT, DURALOC SHELL 60MM, DURALOC CERAMIC 58 OR 60/28 , IMPLANTED IN 2003, NO PROBLEMS TILL 2009, IMMEDIATE PAIN, NECK FRACTURE OF FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL STEM K14S HAC 87LZO; 87MEH LZO DEPUY FRANCE S. A. NA 01106/103617D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention