BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/+5

    MDR report key: 2922092 · Received January 11, 2013

    Report

    Report Number
    2249697-2013-90121
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 22, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K022077
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD¿L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER¿S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE EC YESTERDAY FOR A DISLOCATION THE FEMORAL HEAD DISASSOCIATED FROM THE STEM WHILE TRYING TO DO A CLOSED REDUCTION. THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM THIS MORNING WHERE A NEW INSERT AND HEAD WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18963 V40 COCR LFIT HEAD 36MM/+5 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MLKAD4

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention