BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON CRUC NON BEAD B/P XL1

    MDR report key: 4247853 · Received November 13, 2014

    Report

    Report Number
    0002249697-2014-04264
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K926228
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING FRACTURE INVOLVING A DURACON BASEPLATE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A PHOTOGRAPH OF THE BASEPLATE COMPONENT WAS PROVIDED. THE COMPONENT WAS FRACTURED THROUGH ONE CONDYLE. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR A MEDICAL REVIEW TO BE PERFORMED. DEVICE HISTORY REVIEW: NOT PERFORMED AS THE LOT ID IS UNKNOWN. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS THE LOT ID IS UNKNOWN. CONCLUSIONS: THE PHOTOGRAPHS THAT WERE PROVIDED CONFIRM THAT THE DURACON BASEPLATE WAS FRACTURED. INSUFFICIENT INFORMATION WAS PROVIDED TO PERFORM A MEDICAL REVIEW OF THIS CASE. FURTHER INFORMATION, SUCH AS MEDICAL RECORDS AND DEVICE EVALUATION ARE NEEDED TO DETERMINE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT KNEE DUE TO FAILED KNEE. WHEN SURGEON OPENED UP THE PATIENT, FOUND THAT THE BASEPLATE WAS BROKEN. BASEPLATE, FEMUR AND INSERT WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT KNEE DUE TO FAILED KNEE. WHEN SURGEON OPENED UP THE PATIENT, FOUND THAT THE BASEPLATE WAS BROKEN. BASEPLATE, FEMUR AND INSERT WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734394 DURACON CRUC NON BEAD B/P XL1 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| O| R