BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL KNEE II NON-POROUS STEMMED TIBIA BASEPLATE

    MDR report key: 41829 · Received October 10, 1996

    Report

    Report Number
    41829
    Event Type
    Injury
    Date Received
    October 10, 1996
    Date of Event
    September 3, 1996
    Report Date
    October 9, 1996
    Manufacturer
    INTERMEDICS ORTHOPEDICS, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY DURING 7/96 FOR TREATMENT OF RHEUMATOID ARTHRITIS WITH ENDSTAGE DEGENERATIVE JOINT DISEASE. HE WAS DOING WELL UNITL A FEW WEEKS POSTOPERATIVELY WHEN HE BEGAN TO DEVELOP RECURRENT VARUS DEFORMITY OF THE KNEE AND PAIN. HE HAD DECREASED RANGE OF MOTION. RADIOGRAPHIC TAKEN IN PHYSICIAN'S OFFICE REVEALED SUBSIDENCE OF THE TIBIAL COMPONENT. THE MEDIAL PORTION OF THE IMPLANT APPEARED TO HAVE "SUNK DOWN INTO THE BONE". INTRAOPERATIVELY, IT WAS NOTED THAT THE TIBIAL COMPONENT HAD SUBSIDED ABOUT FIVE OR SIX MILLIMETERS. THE TIBIAL COMPONENT WAS REMOVED AND REPLACED. REMOVED COMPONENTS WERE THE TIBIAL BASEPLATE, TIBIAL STEM, TIBIAL INSERT, AND SPACER. UNDERNEATH THE MEDIAL SIDE, THE BONE WAS FOUND TO BE VERY SOFT. ACUTE INFLAMMATION WAS PRESENT, BUT THERE WAS NO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL KNEE II NON-POROUS STEMMED TIBIA BASEPLATE Implant KNEE PROSTHESIS DEVICE HSH INTERMEDICS ORTHOPEDICS, INC. NA 1246344

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R