BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBONE® I

    MDR report key: 6331797 · Received February 15, 2017

    Report

    Report Number
    1043534-2017-00020
    Event Type
    Injury
    Date Received
    February 15, 2017
    Report Date
    January 24, 2017
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HSN
    PMA / PMN Number
    K051023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: MARK A. PRISSEL (ET AL. A REVIEW OF 399 TOTAL ANKLE REPLACEMENTS: ANALYSIS OF IPSILATERAL SUBTALAR JOINT ARTHRODESIS AND ASSOCIATED TALAR COMPONENT SUBSIDENCE. THE JOURNAL OF FOOT AND ANKLE SURGERY. 2017; 56: 10-14. 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, PER PRISSEL 2017 ET AL, "A REVIEW OF 399 TOTAL ANKLE REPLACEMENTS: ANALYSIS OF IPSILATERAL SUBTALAR JOINT ARTHRODESIS AND ASSOCIATED TALAR COMPONENT SUBSIDENCE", IT WAS REPORTED THAT 5 TOTAL ANKLE REPLACEMENT CASES REQUIRED A REVISION OF THE TALAR COMPONENT. THE FIVE PRIMARY REPORTED MODES OF FAILURE WERE TALAR SUBSIDENCE IN 2 PATIENTS, GUTTER IMPINGEMENT IN 1 PATIENT, OSTEOLYSIS OF THE TALUS IN 1 PATIENT AND HETEROTROPIC OSSIFICATION IN 1 PATIENT. THE MEAN TIME TO FAILURE WAS 25.8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114288 INBONE® I PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention