BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWANSON TITANIUM GREAT TOE IMPLANT

    MDR report key: 1199965 · Received October 16, 2008

    Report

    Report Number
    1043534-2008-00308
    Event Type
    Injury
    Date Received
    October 16, 2008
    Report Date
    October 14, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. EVENT DEVICE CODE IS ADDRESSED IN PACKAGE INSERT. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WEN THE INVESTIGATION IS COMPLETE. THIS LITERATURE SOURCE DID NOT PROVIDE INFORMATION ON THE USER FACILITY, IMPLANTATION DATES, NOR DATES OF COMPLICATIONS. A MEDWATCH 3500A HAS NOT BEEN RECEIVED. (SEE SCANNED PAGES).

    Description of Event or Problem · 1

    IN THE FOOT & ANKLE INTERNATIONAL, VOL. 27, NO. 11, NOVEMBER 2006 ISSUE, DR. KURT FREDERICK KONKEL AND DR. ANDREA GAYLE MENGER PUBLISHED AN ARTICLE TITLED "MID-TERM RESULTS OF TITANIUM HEMI-GREAT TOE IMPLANTS", WHERE 12 (16 TOES) PATIENTS HAD INSERTION OF A TITANIUM HEMI-GREAT TOE IMPLANT. ALLEGEDLY TWO COMPONENTS SHIFTED, ONE COMPONENT HAD SITE ULCER, AND ONE COMPONENT HAD TRAUMA RELATED BREAK. ONE SHIFTED COMPONENT WAS TREATED WITH Z-PLASTY TENDON, SKIN & CAPSULE. THE OTHER SHIFTED COMPONENT WAS TREATED WITH WEIL OSTEOTOMY. THE COMPONENT WITH A SITE ULCER HAD DEBRIDEMENT AND SECONDARY CLOSURE PERFORMED. AND THE BROKEN COMPONENT WAS TREATED WITH DEBRIDEMENT AND CHEILECTOMY MTP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWANSON TITANIUM GREAT TOE IMPLANT NONE LZJ WRIGHT MEDICAL TECHNOLOGY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R