BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 28 +1.5 GR

    MDR report key: 3103175 · Received May 9, 2013

    Report

    Report Number
    1818910-2013-16855
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK843909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    ABOVE IMPLANTS WERE REMOVED FOR UNEXPLAINED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203379 ARTICUL/EZE BALL 28 +1.5 GR HEAD BALL JDI 8010379 DEPUY INTL., LTD. 2290670

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention