BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHS

    MDR report key: 5700453 · Received June 6, 2016

    Report

    Report Number
    3000931034-2016-00074
    Event Type
    Injury
    Date Received
    June 6, 2016
    Report Date
    May 9, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWI
    PMA / PMN Number
    K060438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE SOUR CE OF THIS REPORT IS LITERATURE: IZAÄK F. KODDE, ANDRAS HEIJINK, LAURENS KAAS, PAUL G.H. MULDER, C. NIEK VAN DIJK, AND DENISE EYGENDAAL. PRESS-FIT BIPOLAR RADIAL HEAD ARTHROPLASTY, MIDTERM RESULTS. J SHOULDER ELBOW SURG, 2016 APR 14. PII: S1058-2746(16)00115-4. DOI: 10.1016/J.JSE.2016.02.007. [EPUB AHEAD OF PRINT] HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/27150053.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE THAT: THERE HAD BEEN 3 (11%) REVISIONS (TABLE II). THERE WAS 1 CONVERSION TO A CEMENTED BIPOLAR PROSTHESIS FOR PERSISTENT INSTABILITY (CASE 4). LATER, A CAPITELLAR RESURFACING ARTHROPLASTY AND RECONSTRUCTION OF THE LATERAL COLLATERAL LIGAMENT WOULD BE PERFORMED IN THE SAME PATIENT FOR PERSISTENT INSTABILITY. THERE WAS A SECOND CONVERSION TO A CEMENTED BIPOLAR PROSTHESIS, THIS TIME WITH CONCOMITANT CAPITELLAR RESURFACING ARTHROPLASTY, FOR SYMPTOMATIC ABRASION OF THE CAPITELLUM (IE, PAIN ON THE CAPITELLUM AT PALPATION WITH EROSION OF THE CAPITELLUM AT RADIOGRAPHY; CASE 14). IN BOTH, THE STEMS APPEARED WELL FIXED DURING THE OPERATION; BUT IN THE SECOND CASE, IT HAD TO BE REVISED BECAUSE OF INCOMPATIBILITY WITH THE CAPITELLAR RESURFACING ARTHROPLASTY. IN A THIRD, THE ARTICULATING COMPONENT (IE, HEAD) OF THE PROSTHESIS WAS EXCHANGED FOR A LARGER SIZE FOR INSTABILITY (CASE 3). THE STEM WAS WELL FIXED AND LEFT ALONE. ONE ADDITIONAL PROSTHESIS WAS IN A SUBLUXED POSITION IN RELATION TO THE CAPITELLUM AND WAS CONSIDERED A RADIOLOGIC FAILURE (CASE 29; FIG. 3). IZAAK F. KODDE, ANDRAS HEIJINK, LAURENS KAAS, PAUL G.H. MULDER, C. NIEK VAN DIJK, AND DENISE EYGENDAAL. PRESS-FIT BIPOLAR RADIAL HEAD ARTHROPLASTY, MIDTERM RESULTS. J SHOULDER ELBOW SURG, 2016 APR 14. PII: S1058-2746(16)00115-4. DOI: 10.1016/J.JSE.2016.02.007. [EPUB AHEAD OF PRINT] HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/27150053 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355254 RHS RADIAL HEAD PROSTHESIS KWI TORNIER S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention