BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWANSON TITANIUM BASAL THUMB

    MDR report key: 131039 · Received November 4, 1997

    Report

    Report Number
    131039
    Event Type
    Injury
    Date Received
    November 4, 1997
    Date of Event
    September 17, 1997
    Report Date
    September 25, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KYI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD IMPLANT DONE 9/11 RETURNED TO HOSP C/O OF REDNESS & SWELLING & PAIN IN RIGHT HAND CAST REMOVAL. HAD INFECTED THUMB ORTHOPEDIC PROSTHESIS WITH CELLULITIS OF PT ARM. IMPLANT REMOVED - ANTIBIOTIC STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWANSON TITANIUM BASAL THUMB Implant TITANIUM THUMB IMPLANT KYI WRIGHT MEDICAL TECHNOLOGY, INC. * 047A059440

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention