BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 3192301 · Received June 27, 2013

    Report

    Report Number
    1818910-2013-19983
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    June 19, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    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

    UPDATE: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    MAUDE REPORT ((B)(4)) SUBMITTED BY AN ATTORNEY STATES THAT PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION IN 2012 AND A REVISION SURGERY ON (B)(6) 2013, IN WHICH EVIDENCE OF METALLOSIS AND ALVAL WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293650 ARTICULEZE M HEAD 36MM +1.5 FEMORAL HEAD JDI 8010379 DEPUY INTL., LTD. 2171730

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention