BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBONE(R)

    MDR report key: 7884768 · Received September 18, 2018

    Report

    Report Number
    1043534-2018-00111
    Event Type
    Injury
    Date Received
    September 18, 2018
    Date of Event
    January 1, 2016
    Report Date
    August 22, 2018
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: CHRISTOPHER E. GROSS, MD ET AL. SECONDARY ARTHRODESIS AFTER TOTAL ANKLE ARTHROPLASTY. FOOT & ANKLE INTERNATIONAL. 2016; 37: 709-714. NO CODE: NON-UNION. 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 WRITTEN BY GROSS ET AL TITLED "SECONDARY PROCEDURES IN THIRD GENERATION TOTAL ANKLE ARTHROPLASTIES" IT WAS REPORTED THAT A RETROSPECTIVE STUDY WAS PERFORMED TO STUDY A CONSECUTIVE SERIES OF 1001 PRIMARY TARS PERFORMED BETWEEN JANUARY 1998 AND DECEMBER 2014. THE AUTHOR IDENTIFIED PATIENTS WHO UNDERWENT A SECONDARY TRIPLE, SUBTALAR OR TALONAVICULAR ARTHRODESIS TO TREAT PROGRESSIVE ARTHRITIS OR PES PLANUS DEFORMITY. TWO PATIENTS (7.7%) HAD A DELAYED UNION AND 2 PATIENTS HAD A NONUNION (7.7%) AND WERE CONSIDERED OPERATIVE FAILURES. THERE WERE 3 REPEAT PROCEDURES RELATED TO THE ARTHRODESIS PROCEDURE: 1 CONVERSION OF A SUBTALAR TO A TRIPLE ARTHRODESIS, 1 REVISION TALONAVICULAR FUSION, AND 1 REVISION SUBTALAR FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727317 INBONE(R) PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention