BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWANSON

    MDR report key: 8388237 · Received March 4, 2019

    Report

    Report Number
    1043534-2019-00025
    Event Type
    Injury
    Date Received
    March 4, 2019
    Report Date
    February 3, 2019
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWH
    PMA / PMN Number
    PROSTHESIS,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: RUSHING ET AL. PATIENT-PERCEIVED RECOVERY AND OUTCOMES AFTER SILASTIC IMPLANT ARTHROPLASTY. THE JOURNAL OF FOOT & ANKLE SURGERY. 2018; 57: 1080-1086. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY, IN AN ARTICLE BY RUSHING ET AL, TITLED "PATIENT-PERCEIVED RECOVERY AND OUTCOMES AFTER SILASTIC IMPLANT ARTHROPLASTY" THE AUTHORS REPORT ONE INSTANCE OF REVISION INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180540 SWANSON PROSTHESIS, TOE, CONSTRAINED, POLYMER KWH WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention