BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM*STM ST,30+4L NK,16X11X150

    MDR report key: 3900357 · Received June 27, 2014

    Report

    Report Number
    1818910-2014-22243
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    April 1, 2009
    Report Date
    July 31, 2014
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 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

    CLINICAL REPORT STATES THAT PATIENT EXPERIENCED A LARGE, COAGULATED HEMATOMA IN CONJUNCTION WITH ACTIVE ARTERIAL BLEEDING INFERIOR TO THE ACETABULUM TREATED WITH IRRIGATION, DEBRIDEMENT AND EVACUATION OF HEMATOMA WITH CAUTERIZATION OF BLEEDER 36 DAYS AFTER PRIMARY THA. DOI: UNKNOWN DOR: NOT REVISED (HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. 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

    CLINICAL REPORT STATES THAT PATIENT EXPERIENCED A LARGE, COAGULATED HEMATOMA IN CONJUNCTION WITH ACTIVE ARTERIAL BLEEDING INFERIOR TO THE ACETABULUM TREATED WITH IRRIGATION, DEBRIDEMENT AND EVACUATION OF HEMATOMA WITH CAUTERIZATION OF BLEEDER 36 DAYS AFTER PRIMARY THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376587 SROM*STM ST,30+4L NK,16X11X150 HIP FEMORAL STEM/SLEEVE JDI DEPUY (IRELAND) 9616671 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention