BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER

    MDR report key: 1883825 · Received October 22, 2010

    Report

    Report Number
    9610667-2010-00009
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    June 21, 2010
    Report Date
    October 22, 2010
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    PMA / PMN Number
    K061439
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT DETAILS HAVE BEEN RELEASED TO TORNIER AND ARE NOT ANTICIPATED. THE DEVICE REQUIRED WAS NOT SUPPLIED, THEREFORE SERIAL NUMBER, DATE OF MFR AND ASSESSMENT OF A DEVICE RETURN CANNOT BE PROVIDED/ACCOMPLISHED. TORNIER SUPPLIES THE SURGICAL SUITE WITH AN ARRAY OF IMPLANT ON SPECIFIC FACILITY REQUEST. NO CLINICALLY DISTRIBUTED PRODUCT IS AFFECTED. TORNIER HAS ADJUSTED THE REQUIREMENTS OF THE IMPLANT ARRAY FOR SPECIFIC BIO-RSA SURGICAL EVENTS TO ASSURE ALL NEEDED COMPONENTRY AND OPTIONS ARE PROVIDED. NO FURTHER ACTION OR INFO IS ANTICIPATED FOR THIS EVENT.

    Description of Event or Problem · 1

    TORNIER SUPPLIED A SURGICAL IMPLANTS TRAY FOR A SHOULDER REPLACEMENT CASE. THE SURGICAL APPROACH INTENDED WAS IDENTIFIED AS A BIO-RSA TECHNIQUE. THIS APPROACH REQUIRES A LONG POST GLENOID BASEPLATE BE EMPLOYED (TORNIER (B)(4)). THIS IMPLANT COMPONENT WAS NOT INCLUDED/PROVIDED BY TORNIER FOR THIS SURGICAL CASE. THE SURGEON IMPLANTED THE AVAILABLE SHORT POST GLENOID BASEPLATE ((B)(4)) WHICH CLINICALLY DISLOCATED ONE DAY POST OPERATIVELY. THIS SHORT POST BASEPLATE WAS EXPLANTED AND REPLACED THREE DAYS AFTER THE INITIAL SURGERY. NO FURTHER PT INFO HAS BEEN PROVIDED. TORNIER FAILURE TO SUPPLY THE APPROPRIATE COMPONENT DIRECTLY RESULTED IN THE REQUIREMENT FOR REVISION SURGERY. THE EVENT REPORTED OCCURRED IN (B)(6) WITH A TORNIER DEVICE THAT IS ALSO USA DISTRIBUTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER PROSTHESIS, SHOULDER, SEMI-CONSTRAINED KWS TORNIER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R