BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 28 +1.5 GR

    MDR report key: 2121676 · Received June 2, 2011

    Report

    Report Number
    1818910-2011-09683
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K883460
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE PROVIDED INFORMATION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THE INVESTIGATION HAS ALSO DETERMINED THE LINER AND HOLE ELIMINATOR PRODUCT CODES ARE NOW OBSOLETE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF PAIN. OSTEOLYSIS AND POLY WEAR WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICUL/EZE BALL 28 +1.5 GR 87 JDI JDI DEPUY ORTHOPAEDICS, INC. NA 812590005

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention