BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 529119 · Received June 10, 2004

    Report

    Report Number
    529119
    Event Type
    Injury
    Date Received
    June 10, 2004
    Date of Event
    March 1, 2004
    Report Date
    May 28, 2004
    Manufacturer
    UNK
    Product Code
    KWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO HOSPITAL FOR REMOVAL OF RETAINED SILASTIC PROSTHESIS OF LEFT WRIST SECONDARY TO LEFT WRIST SWELLING, PAIN, NUMBNESS, TINGLING, AND BURNING IN BOTH ARMS. DURING SURGERY IT WAS NOTED THAT PT HAD EXTENSIVE SYNOVITIS, DIFFUSE CARPAL, RADIAL, AND ULNAR EROSION DUE TO SYNOVITIS. SURGEON PERFORMED EXCISION OF FRAGMENTED IMPLANT, INTERPOSTIONAL ARTHROPLASTY DISTAL RADIAL ULNAR JOINT, WRIST ARTHRODESIS PROXIMAL ROW CARPECTOMY, AND EXTENSIVE EXCISION OF INTERCARPAL AND INTER RADIAL SYNOVITIC EROSION. THE ORIGINAL IMPLANT WAS PLACED 17 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SILASTIC WRIST PROSTHESIS KWM UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention