BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC 300 SERIES 50MM OD

    MDR report key: 2780810 · Received October 10, 2012

    Report

    Report Number
    1818910-2012-23288
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    JDL
    PMA / PMN Number
    K900891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DUE TO THE LENGTH OF TIME BETWEEN DATE OF INSERTION AND DATE OF REVISION, IT WOULD NOT BE UNEXPECTED TO OBSERVE THE ALLEGED FINDINGS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS CUP LOOSENING AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURALOC 300 SERIES 50MM OD ACETABULAR CUP JDL DEPUY RAYNHAM 713700

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention