BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBONE TOTAL ANKLE SYSTEM

    MDR report key: 7898022 · Received September 21, 2018

    Report

    Report Number
    1043534-2018-00146
    Event Type
    Injury
    Date Received
    September 21, 2018
    Report Date
    August 22, 2018
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: HYOJEONG MULCAHY ET AL. CURRENT CONCEPTS IN TOTAL ANKLE REPLACEMENT FOR RADIOLOGISTS: COMPLICATIONS. AJR. 2015; 205:1244-1250. 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, IT WAS REPORTED BY MULCAHY ET AL IN AN ARTICLE TITLED "CURRENT CONCEPTS IN TOTAL ANKLE REPLACEMENT FOR RADIOLOGISTS: COMPLICATIONS" THAT A PATIENT SUFFERED A POSTOPERATIVE PERIPROSTHETIC STRESS FRACTURE IN THE INBONE II PROSTHESIS 3 MONTHS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739606 INBONE TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention