BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 LAT COXA VARA SIZE 12

    MDR report key: 4102077 · Received September 19, 2014

    Report

    Report Number
    1818910-2014-28498
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST
    Product Code
    KWY
    PMA / PMN Number
    PK123991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    PATIENT WAS REVISED TO ADDRESS DISLOCATION CAUSED BY LOOSENING OF THE FEMORAL STEM AND FEMUR FRACTURE. DATE OF FRACTURE IS UNKNOWN. DOI (B)(6) 2014 DOR (B)(6) 2014 (RIGHT HIP).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. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION CAUSED BY LOOSENING OF THE FEMORAL STEM AND FEMUR FRACTURE. DATE OF FRACTURE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582535 CORAIL2 LAT COXA VARA SIZE 12 HIP FEMORAL STEM/SLEEVE KWY 3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST 5227140

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention