BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE CER BALL 32+1

    MDR report key: 2002196 · Received February 18, 2011

    Report

    Report Number
    1818910-2011-02571
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    LZO
    PMA / PMN Number
    K931024
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    PATIENT REVISED FOR STEM/CUP IMPINGEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICUL/EZE CER BALL 32+1 87LZO LZO DEPUY INTL., LTD. NA 1803110

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention