BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 13

    MDR report key: 1945492 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-10530
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    LZO
    PMA / PMN Number
    K042992
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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

    PATIENT WAS REVISED TO ADDRESS ACETABULAR AND SUSPECTED FEMORAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 NON COL HO SIZE 13 87LZO 87KWA 87MEH 87LWJ LZO DEPUY FRANCE S.A. NA 1904420

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention