BEUDAMED
    FDA Adverse Event Other Summary report: N

    WHITESIDE ORTHO II PATELLA

    MDR report key: 69701 · Received February 13, 1997

    Report

    Report Number
    69701
    Event Type
    Other
    Date Received
    February 13, 1997
    Date of Event
    December 31, 1996
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HTG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INITIAL TOTAL KNEE REPLACEMENT 4/16/84. REFERRED BACK TO ORTHOPEDIC SURGEON ON 10/1/96 COMPLAINING OF INCREASED KNEE PAIN AND CATCHING. PT ADMITTED FOR SURGERY ON 12/31/96 FOR ARTHROSCOPY AND EXAM OF PROSTHESIS. IN SURGERY FOUND THAT POLYETHYLENE PATELLAR COMPONENT HAD FRAGMENTED INTO MULTIPLE PIECES. TWO LARGE FRAGMENTS AND ONE SMALL FRAGMENT WERE REMOVED -- PIECES PARTIALLY MISSING. SURGEON PLANS ON FUTURE REVISION OF THE PATELLOFEMORAL INTERVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESIDE ORTHO II PATELLA Implant ARTIFICIAL PATELLA IMPLANT HTG WRIGHT MEDICAL TECHNOLOGY, INC. * 11322021

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other