BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL KNEE IDE PATELLA SZI

    MDR report key: 47843 · Received November 12, 1996

    Report

    Report Number
    2935620-1996-00009
    Event Type
    Injury
    Date Received
    November 12, 1996
    Date of Event
    September 19, 1996
    Report Date
    November 11, 1996
    Manufacturer
    INTERMEDICS ORTHOPEDICS, INC.
    Product Code
    HTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IDE REVISION SURGERY (G870035 #0201-256/LT) PT HAD A PAST HISTORY OF SUSTAINING A FALL, LANDING ON HER BILATERAL KNEES WITH KNEE PAIN. ON PRESENTATION, REPORTED PAIN HAD BEEN PRESENT SINCE LAST JANUARY AND HAD BEEN UNABLE TO AMBULATE OVER THE PAST MONTH. SHE REQUIRED A WHEELCHAIR FOR AMBULATION. SHE IS STATUS POST A RIGHT TOTAL KNEE ARTHROPLASTY DURING 1989, A LEFT TOTAL KNEE ARTHROPLASTY DURING 1990, AND A LEFT PATELLA REALIGNMENT AFTER THE SUSTAINED FALL IN 1996. PT WAS TAKEN TO SURGERY FOR REVISION OF THE RIGHT TOTAL KNEE PROSTHESIS. QUADRICEP TENDON WAS FOUND TO BE EITHER AVULSED OR RUPTURED FROM THE PATELLA. UPON OPENING KNEE, SHE WAS NOTED TO HAVE SOME FRAGMENTS OF POLY, WHICH WERE DEBRIDED. MINIMAL EROSION AROUND THE ANTERIOR ASPECT OF THE TIBIAL BASEPLATE. SYNOVIUM OF THE KNEE WAS DISCOLORED. A SYNOVECTOMY WAS PERFORMED AND FLAKES OF POLYETHYLENE, AS WELL AS SOME DEBRIS WAS FOUND WITHIN THE SYNOVIUM. POLYETHELYNE HAD DETAMINATED OFF THE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL KNEE IDE PATELLA SZI Implant KNEE IMPLANT PROTHESIS HTG INTERMEDICS ORTHOPEDICS, INC. NA 16493-A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 6201-00-021