BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4221773 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04154
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT WAS CONFIRMED BY A PHOTOGRAPH OF THE DEVICE ATTACHED TO THE PI INTAKE TAB, BUT DID NOT ADD ANYTHING MEANINGFUL TO THE INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A ROOT CAUSE CANNOT BE DETERMINED. THE EVENT WAS CONFIRMED BY A PHOTOGRAPH OF THE FRACTURED INSERT. HOWEVER, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE 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.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN INSERT. WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SURGEON WAS ABOUT TO DO REVISION OF OLD STRYKER IMPLANT DUE TO INSTABILITY. AS SOON AS THE INCISIONS WERE TAKEN AND SURGERY STARTED , IT WAS OBSERVED THAT INSERT WAS LYING BROKEN INSIDE THE TIBIAL IMPLANT . THE PREVIOUS SURGERY WAS DONE 4 YEARS BACK AND THIS POINT WAS HIGHLIGHTED BY SURGEON THAT IN 4 YEARS INSERT IS BROKEN.

    Description of Event or Problem · 1

    SURGEON WAS ABOUT TO DO REVISION OF OLD STRYKER IMPLANT DUE TO INSTABILITY. AS SOON AS THE INCISIONS WERE TAKEN AND SURGERY STARTED , IT WAS OBSERVED THAT INSERT WAS LYING BROKEN INSIDE THE TIBIAL IMPLANT . THE PREVIOUS SURGERY WAS DONE 4 YEARS BACK AND THIS POINT WAS HIGHLIGHTED BY SURGEON THAT IN 4 YEARS INSERT IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703798 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention