BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTO TALARIS PROSTHESIS

    MDR report key: 6236828 · Received January 10, 2017

    Report

    Report Number
    3000931034-2017-00014
    Event Type
    Injury
    Date Received
    January 10, 2017
    Report Date
    December 16, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    HSN
    PMA / PMN Number
    K130533
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE SOURCE OF THIS REPORT IS LITERATURE : JOHN CHAO MD, JAE HYUCK CHOI MD, BENJAMIN J. GEAR MD, SHAY TENENBAUM MD, JASON T. BARITEAU MD, JAMES W. BRODSKY MD. "EARLY RADIOGRAPHIC AND CLINICAL RESULTS OF SALTO TOTAL ANKLE ARTHROPLASTY AS A FIXED BEARING DEVICE" FOOT & ANKLE SURGERY 21 (2015) 91-96.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE THAT THE PATIENT HAD LOOSENING AND SEVERE SUBSIDENCE OF THE TIBIAL COMPONENT, WHICH REQUIRED REMOVAL OF THE PROSTHESIS. CONVERSION TO ANKLE ARTHRODESIS. JOHN CHAO MD, JAE HYUCK CHOI MD, BENJAMIN J. GEAR MD, SHAY TENENBAUM MD, JASON T. BARITEAU MD, JAMES W. BRODSKY MD. "EARLY RADIOGRAPHIC AND CLINICAL RESULTS OF SALTO TOTAL ANKLE ARTHROPLASTY AS A FIXED BEARING DEVICE" FOOT & ANKLE SURGERY 21 (2015) 91-96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19966 SALTO TALARIS PROSTHESIS ANKLE PROSTHESIS HSN TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other