BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM*STM LG 36+8L 22X17X230R

    MDR report key: 3882952 · Received June 19, 2014

    Report

    Report Number
    1818910-2014-21490
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    January 14, 2002
    Report Date
    May 27, 2014
    Manufacturer
    DEPUY (IRELAND) 9616671
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REVISED TO ADDRESS A PROXIMAL FEMUR FRACTURE 5 DAYS AFTER IMPLANT OF THE FEMORAL STEM. (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE BASED ON THE INFORMATION AVAILABLE, IT CANNOT BE DETERMINED IF THE COMPLAINT IS PRODUCT RELATED. 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.

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS A PROXIMAL FEMUR FRACTURE 5 DAYS AFTER IMPLANT OF THE FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361174 SROM*STM LG 36+8L 22X17X230R HIP FEMORAL STEM/SLEEVE JDI DEPUY (IRELAND) 9616671 710960

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention