BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE M 36MM +8.5

    MDR report key: 3200871 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20324
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 30, 2013
    Report Date
    June 23, 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
    PHYSICIAN

    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

    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 POST OPERATIVE X-RAYS REVIEW FOUND QUALITY IS POOR DUE TO DIGITAL CAMERA PICTURE OF X-RAY ON LIGHT BOX. THE CUP SEEMS TO HAVE VERY LITTLE BONE AROUND IT MEDIALLY AS COMPARED TO THE OPPOSITE HIP AND THE PROXIMAL FEMUR IS MUCH CLOSER TO THE PELVIS , LEG OFFSET SEEMS LOW, AS COMPARED TO THE CONTRALATERAL SIDE. HOWEVER, THIS MAY BE DUE TO LEG POSITIONING DURING THE X-RAY PROCEDURE. NO CONCLUSIONS CAN BE DRAWN. 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.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013. FEMORAL HEAD DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303354 ARTICUL/EZE M 36MM +8.5 HEAD BALL JDI 8010379 DEPUY INTL., LTD. 2046892

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention