BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 3081085 · Received April 26, 2013

    Report

    Report Number
    1818910-2013-16143
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    June 6, 2011
    Report Date
    April 3, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. REG. # 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

    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 REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REASON FOR REVISION WAS NOT PROVIDED AND THEREFORE NO CONCLUSIONS CAN BE DRAWN. FURTHER INFORMATION REGARDING THIS REPORT WAS NOT MADE AVAILABLE TO CUSTOMER QUALITY. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. 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

    REOPENED 11 JUNE 2014 AS FULL PRODUCT CODES RECEIVED AND UPDATED. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 1861873 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. PER WI-3430, A REVIEW OF THE DEVICE HISTORY RECORDS IS NO LONGER REQUIRED FOR THE 2001730 AND 2004526 LOT CODES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED COMPLAINTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. 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

    CONFIRMED REVISION OF PINNACLE/CORAIL IMPLANTS. REASON NOT PROVIDED, REVISION DATE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180966 ARTICULEZE M HEAD 36MM +1.5 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. REG. # 8010379 2004526

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention