BEUDAMED
    FDA Adverse Event Other Summary report: N

    WRIGHT MEDICAL TECHNOLOGIES, INC.

    MDR report key: 221970 · Received May 4, 1999

    Report

    Report Number
    221970
    Event Type
    Other
    Date Received
    May 4, 1999
    Date of Event
    March 22, 1999
    Report Date
    March 29, 1999
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTS WITH RECALCITRANT PAIN, STATUS POST LEFT TOTAL KNEE, ARTHROPLASTY, WITH LACK OF RANGE OF MOTION, PROBABLE LOOSENING TIBIAL COMPONENT. SURGICAL NOTES: ON ENTERING THE KNEE, THERE WAS 30 CC OF CLEAR SYNOVIAL FLUID. IN ADDRESSING THE TIBIAL COMPONENT, THERE WAS A MARKED OVERHANG OF APPROX 5 MM OF THE TIBIAL PLASTIC; THIS COULD BE SEEN TO BE ROCKING BACK AND FORTH WITH RANGE OF MOTION. THE POLYETHYLENE HAD DISSOCIATED FROM THE DOVETAIL MECHANISM OF THE ORTHOMET KNEE. THIS WAS THEN REMOVED. REPLACEMENT SURGERY PERFORMED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRIGHT MEDICAL TECHNOLOGIES, INC. Implant TOTAL KNEE JWH WRIGHT MEDICAL TECHNOLOGY SEE SECTION 6 077A068058

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other