BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER AEQUALIS REVERSE SHOLDER PROSTHESIS

    MDR report key: 1408836 · Received June 18, 2009

    Report

    Report Number
    9610667-2009-00004
    Event Type
    Malfunction
    Date Received
    June 18, 2009
    Date of Event
    May 18, 2009
    Report Date
    June 19, 2009
    Manufacturer
    TORNIER INC.
    Product Code
    HSD
    PMA / PMN Number
    041873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPONENTS INVOLVED: DWB945 CEMENTED STEM DIA 9MM LG 100MM (B)(4) - MANUFACTURED JANUARY 2009: K030941. DWB991 HEMI-PROSTHESIS ADAPTATOR DIA 36MM (B)(4) - MANUFACTURE AUGUST 2007: K041873. DWB248 HUMERAL HEAD (B)(4) - MANUFACTURED APRIL 2007 : K994392. DEVICES HAVE BEEN RETURNED AND RESULTS OF ENGINEERING ANALYSIS IS PENDING. ADDITIONAL COMPONENTS IN USE WITH THIS PT EVENT; DWB960 CEMENTED METAPHYSIS DIA 36MM (B)(4) - MANUFACTURED FEBRUARY 2009: K030941. DWB990 ADAPTATOR/METAPHYSIS UNION SCREW (B)(4) - MANUFACTURED FEBRUARY 2007: K041873.

    Description of Event or Problem · 1

    (B)(4). UFR FORWARDED BY USER WITH PRODUCT AND FDA BY MAIL. ADDITIONALLY, A LETTER OF INQUIRY FOR ADDITIONAL MATERIALS HAS BEEN RECEIVED FROM FDA DATED 28 MAY 09. EVENT: THE PT WAS SCHEDULED FOR A REVERSE TOTAL SHOULDER PROCEDURE. UPON THE CLINICAL DETERMINATION THAT INSUFFICIENT GLENOID SURFACE WAS PRESENT TO PROCEED WITH THIS APPROACH, THE SURGEON INTENDED TO MODIFY THE APPROACH TO THAT OF A HEMI SHOULDER. IT WAS FOUND DURING PRE-IMPLANT ASSEMBLY ON THE SURGICAL BENCH, THAT THE PROVIDED HEMI PROSTHESIS ADAPTOR COMPONENT COULD NOT BE MATED WITH THE HUMERAL HEAD COMPONENT AND CEMENTED STEM COMPONENT TO ACCOMMODATE THIS CHANGE IN SURGICAL INTENT. THIS IS THE NATURE OF THE MALFUNCTION REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A COMPETITOR PRODUCT, BRAN IDENTIFY UNCERTAIN. NO TORNIER DEVICE WAS IMPLANTED IN THIS PROCEDURE. NO PT INJURY OCCURRED. NO DELAY OF SURGERY OCCURRED. THE FAILED UNITS HAVE BEEN RETURNED FOR ENGINEERING REVIEW. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER AEQUALIS REVERSE SHOLDER PROSTHESIS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED HSD TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR