BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL2 LAT COXA VARA SIZE 11

    MDR report key: 1983178 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01417
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWA
    PMA / PMN Number
    K123991
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    PT WAS REVISED TO ADDRESS STEM LOOSENING SECONDARY TO METAL-ON-METAL DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 LAT COXA VARA SIZE 11 87KWA; 87LZO; 87MEH; 87LWJ KWA DEPUY FRANCE S.A. NA 2774661

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention