BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURON SHOULDER

    MDR report key: 4192688 · Received October 22, 2014

    Report

    Report Number
    1644408-2014-00660
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K080402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS THE RESULT OF A PATIENT TEARING THEIR ROTATOR CUFF WHILE WORKING OUT AFTER 4.5 MONTHS IN VIVO. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT AGAINST LOT NUMBER 878C1307. THE EVENT IS THE RESULT OF PATIENT TRAUMA CAUSED BY AN EXERCISE THAT TORE THE PATIENTS ROTATOR CUFF. THERE IS NO REASON TO BELIEVE A FAILURE OF THE COMPONENTS WOULD HAVE OCCURRED WITHOUT A PATIENT TRAUMA. NO OTHER CONDITIONS RELATING TO THIS EVENT COULD BE DETERMINED WITH CONFIDENCE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT TEARING THEIR ROTATOR CUFF WHILE WORKING OUT. THE SURGEON REMOVED THE HUMERAL NECK, HUMERAL HEAD, AND THE GLENOID THEN CONVERTED TO A REVERSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673359 TURON SHOULDER TURON HUMERAL NECK, NEUTRAL KWS ENCORE MEDICAL, L.P. 878C1307

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 520-54-018, LOT 939C1026| 521-01-254, LOT 802N1002