BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 28 +8.5 BL

    MDR report key: 1013762 · Received March 13, 2008

    Report

    Report Number
    1818910-2008-00731
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 19, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    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

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PROD AND LOT CODES, SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PROD AND/OR ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS CHRONIC DISLOCATION; POLY WEAR OF THE LINER WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICUL/EZE BALL 28 +8.5 BL 87JDI JDI DEPUY ORTHOPAEDICS, INC. NA U3YEE1013

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention