BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 3192879 · Received June 27, 2013

    Report

    Report Number
    1818910-2013-20001
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. 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 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.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2013-27446R. THIS REPORT, 1818910-2013-20001, WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2013-27446.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM (B)(6)'S. CONFIRMED REVISION OF PINNACLE/CORAIL IMPLANTS. A PINNACLE PROSTHESSIS WAS IMPLANTED IN 2009 AND NEEDED TO BE REVISED (DATE NOT PROVIDED). PATIENT SUFFERS FROM THE MEDICAL CONSEQUENCES OF THE METAL ON METAL IMPLANT SUCH AS PAIN AND METALLOSIS. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    CONFIRMED REVISION, PATIENT SUFFERS FROM THE MEDICAL CONSEQUENCES OF THE METAL ON METAL IMPLANT SUCH AS PAIN AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294778 ARTICULEZE M HEAD 36MM +5 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. 8010379 2832567

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention