BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUTURA GREAT TOE

    MDR report key: 5268301 · Received December 4, 2015

    Report

    Report Number
    3004983210-2015-00074
    Event Type
    Injury
    Date Received
    December 4, 2015
    Date of Event
    April 1, 2013
    Report Date
    December 2, 2014
    Manufacturer
    TORNIER INC.
    Product Code
    KWH
    PMA / PMN Number
    K981194
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. REPORT BASED ON LITERATURE: A RETROSPECTIVE REVIEW OF THE PRIMUS FIRST MTP JOINT DOUBLE-STEMMED SILICONE IMPLANT. LAWRENCE BR, THUEN E. FOOT ANKLE SPEC. 2013 APR;6(2):94-100. DOI: 10.1177/1938640012470715 HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/23291555.

    Description of Event or Problem · 1

    AS STATED IN THE ABSTRACT OF THE ARTICLE: "IMPLANT ARTHROPLASTY HAS BEEN A SURGICAL ALTERNATIVE FOR CORRECTION OF HALLUX RIGIDUS FOR MANY DECADES. A STUDY IS PRESENTED REVIEWING THE AUTHORS' EXPERIENCE USING THE (TORNIER/FUTURA) PRIMUS DOUBLE-STEMMED SILICONE IMPLANT. A TOTAL OF 144 PATIENTS REPRESENTING 201 IMPLANTS WERE IDENTIFIED AND INVITED TO PARTICIPATE IN THE STUDY. THE POSTOPERATIVE PERIOD RANGED FROM 32 TO 108 MONTHS, WITH AN AVERAGE OF 66.4 MONTHS. CHART REVIEW WAS PERFORMED ON ALL CASES. THIS REVIEW REVEALED THAT THERE WERE 2 IMPLANTS THAT HAD BEEN REMOVED, EACH FOR REASONS OTHER THAN IMPLANT BREAKDOWN. SEVERAL INDICATIONS IN ADDITION TO HALLUX RIGIDUS WERE FOUND, INCLUDING HALLUX VALGUS WITH ARTHRITIS, GERIATRIC BUNION, RHEUMATOID ARTHRITIS, AND IATROGENIC AND TRAUMATIC ARTHRITIS. THE OUTCOMES ARE PRESENTED FOR ALL PATIENTS, WITH ADDITIONAL BREAKDOWN BY THEIR INDICATION FOR SURGERY. IN ALL, 54 PATIENTS INVOLVING 70 IMPLANTS RESPONDED AND WERE CLINICALLY EVALUATED. THIS STUDY INCLUDED A VISUAL ANALOGUE SCALE, FOOT AND ANKLE (VAS FA) PATIENT OUTCOME AND SATISFACTION QUESTIONNAIRE, CLINICAL EXAMINATION, AND X-RAY EVALUATION. PATIENTS WITH HALLUX RIGIDUS HAD AN AVERAGE POSTOPERATIVE AMERICAN ORTHOPAEDIC FOOT AND ANKLE SOCIETY (AOFAS) SCORE OF 88.2, AND THOSE WITH HALLUX VALGUS WITH ARTHRITIS HAD AN AVERAGE SCORE OF 88.6. THE AVERAGE AOFAS SCORE FOR ALL PATIENTS WAS 87.4. THE AVERAGE VAS PATIENT SATISFACTION FOR ALL PATIENTS WAS 8.5 (WITH 10 BEING HIGHEST SATISFACTION). IMPLANT ARTHROPLASTY CONTINUES TO BE A VIABLE ALTERNATIVE FOR SURGICAL CORRECTION OF HALLUX RIGIDUS AS WELL AS OTHER DEGENERATIVE CONDITIONS OF THE FIRST MTP JOINT. THIS PROCEDURE IS PARTICULARLY EFFECTIVE IN OLDER, LESS-ACTIVE PATIENTS WITH LOWER FUNCTIONAL DEMAND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798821 FUTURA GREAT TOE FLEXIBLE GREAT TOE IMPLANT KWH TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention