BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 289 +8.5BL

    MDR report key: 1892332 · Received November 2, 2010

    Report

    Report Number
    1818910-2010-08304
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    June 5, 2009
    Report Date
    June 5, 2009
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JDI
    PMA / PMN Number
    K883460
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 WAS REVISED TO ADDRESS PAIN AND INSTABILITY. POLY WEAR OF THE LINER WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICUL/EZE BALL 289 +8.5BL 87JDI JDI DEPUY INTERNATIONAL, LTD. NA YFL48

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention