BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3970126 · Received July 31, 2014

    Report

    Report Number
    0002249697-2014-02939
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN GMRS DISTAL FEMUR. ADDITIONAL DEVICES LISTED IN THIS REPORT: UNKNOWN GMRS PROXIMAL TIBIA. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICES IMPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY COULD NOT BE PERFORMED BECAUSE THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED NOR WAS A VALID LOT CODE PROVIDED. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT HAS A GMRS DISTAL FEMUR AND PROXIMAL TIBIA IS INFECTED. PATIENT REFUSED AMPUTATION.

    Description of Event or Problem · 1

    PATIENT HAS A (B)(6) DISTAL FEMUR AND PROXIMAL TIBIA IS INFECTED. PATIENT REFUSED AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446803 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other