BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 28 +1.5 GR

    MDR report key: 1945497 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-09822
    Event Type
    Injury
    Date Received
    December 30, 2010
    Report Date
    December 2, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K883460
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE BY DEPUY INTERNATIONAL DID NOT REVEAL ANY RELATED PRODUCT PROBLEMS, MANUFACTURING DEVIATIONS OR ANOMALIES. IT WAS REPORTED THAT PATIENT X-RAYS WOULD NOT BE PROVIDED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION CAN DRAW NO CONCLUSIONS REGARDING THE REPORTED EVENT. ALTHOUGH, INVESTIGATION FINDS IT MAY BE THAT THE PATIENT ACTIVITY LEVEL AND ACTIVITIES ARE CONTRIBUTORY FACTORS. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. MONITOR THROUGH TREND ANALYSIS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICUL/EZE BALL 28 +1.5 GR 87JDI JDI DEPUY ORTHOPAEDICS, INC. NA D10071090

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention