BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 28 +1.5 GR

    MDR report key: 1945488 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-10548
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (DEPUY-SUZHOU) LTD.
    Product Code
    JDI
    PMA / PMN Number
    K883460
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    PT WAS REVISED TO ADDRESS DISLOCATION. IT WAS REPORTED THAT THE PT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICUL/EZE BALL 28 +1.5 GR 87 JDI JDI JOHNSON & JOHNSON MEDICAL (DEPUY-SUZHOU) LTD. NA D09080609

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention