BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWANSON FINGER JOINT

    MDR report key: 8199205 · Received December 27, 2018

    Report

    Report Number
    1043534-2018-00203
    Event Type
    Injury
    Date Received
    December 27, 2018
    Report Date
    December 4, 2018
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: BALES ET AL. A LONG-TERM RESULTS OF SWANSON SILICONE ARTHROPLASTY FOR PROXIMAL INTERPHALANGEAL JOINT OSTEOARTHRITIS. J HAND SURG AM. 2014; 39: 455-461. 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 A 2009 LITERATURE ARTICLE, BY BALES ET AL. TITLED ALONG-TERM RESULTS OF SWANSON SILICONE ARTHROPLASTY FOR PROXIMAL INTERPHALANGEAL JOINT OSTEOARTHRITIS, THE AUTHORS DISCUSS 3 REVISIONS OF SWANSON PIP JOINT ARTHROPLASTY DUE TO SYMPTOMATIC IMPLANT BREAKAGE, AND 1 REVISION DUE TO INFECTION. THE AUTHORS ALSO STATE THAT "ALL PATIENTS EXHIBITED SOME DEGREE OF INSTABILITY INHERENT IN THE DESIGN OF THE SILICONE IMPLANT." ADDITIONALLY, THE AUTHORS STATE THAT THERE WERE 21 CASES OF IMPLANT FRACTURE IN SITU, 15 CASES OF RADIOLUCENCY ADJACENT TO THE IMPLANT, AND 29 CASES OF SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039993 SWANSON FINGER JOINT PROSTHESIS, FINGER, POLYMER KWF WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention