BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-KNEE MOD. TIBIAL BEAR INS.

    MDR report key: 4123290 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03646
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HSX
    PMA / PMN Number
    K896856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED. THE INVESTIGATION DETERMINED THE LIKELY ROOT CAUSE OF THE REPORTED ORANGE STAIN OF THE ARTICULATING SURFACE WAS DERIVED FROM BIOLOGICAL FLUID AS REPORTED IN THE MATERIALS ANALYSIS REPORT. THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED DUE TO LOOSENING. AT THE REVISION SURGERY, THE ORANGE STAINS WERE FOUND ON THE INSERT. THE SURGEON WOULD LIKE TO KNOW THE ELEMENTS OF THE ORANGE STAINS.

    Description of Event or Problem · 1

    THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED DUE TO LOOSENING. AT THE REVISION SURGERY, THE ORANGE STAINS WERE FOUND ON THE INSERT. THE SURGEON WOULD LIKE TO KNOW THE ELEMENTS OF THE ORANGE STAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602834 UNI-KNEE MOD. TIBIAL BEAR INS. PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER HSX STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other