BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRH FEMORAL COMPONENT

    MDR report key: 3875354 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02320
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Description of Event or Problem · 1

    REVISION OF RIGHT KRH FEMUR. METAL CONDYLE WAS BROKEN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352539 KRH FEMORAL COMPONENT IMPLANT HSA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention