BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOW CORNING WRIGHT

    MDR report key: 116773 · Received August 28, 1997

    Report

    Report Number
    116773
    Event Type
    Injury
    Date Received
    August 28, 1997
    Date of Event
    August 14, 1997
    Report Date
    August 28, 1997
    Manufacturer
    DOW CORNING WRIGHT
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RIGHT TOTAL KNEE ARTHROPLASTY. PAIN HAS INCREASED, BECOMING SEVERE. EXAM - DIFFUSE PAIN - NO INTRA ARTICULAR SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOW CORNING WRIGHT Implant TOTAL CONDYLAR TIBIAL INSERT JWH DOW CORNING WRIGHT * 052M743200

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention