BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWANSON FINGER JOINT IMPLANT

    MDR report key: 1623724 · Received March 4, 2010

    Report

    Report Number
    1043534-2010-00068
    Event Type
    Injury
    Date Received
    March 4, 2010
    Report Date
    February 25, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS LITERATURE SOURCE DID NOT PROVIDE INFO ON THE IMPLANTATION DATES, NOR DATES OF COMPLICATIONS. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B) (6).

    Description of Event or Problem · 1

    PER ARTICLE "AVANTA VERSUS SWANSON SILICONE IMPLANTS IN THE MCP JOINT--A PROSPECTIVE, RANDOMIZED COMPARISON OF 30 PTS FOLLOWED FOR 2 YRS", IN THE J HAND SURG BR. 2005 FEB;30(1):8-13., MOLLER K, SOLLERMAN C, GEIJER M, KOPYLOV P, AND TAGIL M. REPORT "FRACTURE OF THE SILICONE SPACER OCCURRED WITH 8 SWANSON IMPLANTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWANSON FINGER JOINT IMPLANT SMALL JOINT COMPONENT KWF WRIGHT MEDICAL TECHNOLOGY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R