BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURON SHOULDER

    MDR report key: 3961484 · Received July 28, 2014

    Report

    Report Number
    1644408-2014-00481
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K080402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS FOR JOINT INSTABILITY AND A TORN ROTATOR CUFF. THE IN-VIVO LENGTH OF SERVICE FOR THE PRODUCT WAS 2.5 MONTHS. 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. (B)(4). THE ROOT CAUSE FOR THIS PRODUCT COMPLAINT IS THE RESULT OF THE PATIENT FALLING FROM A LADDER. THE FALL RESULTED IN INSTABILITY AND TORN ROTATOR CUFF IN THE PATIENT'S SHOULDER. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT SUFFERED AN INJURY FROM FALLING OFF A LADDER. THE FALL CAUSED INSTABILITY AND THE ROTATOR CUFF WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437509 TURON SHOULDER PRIMARY HUMERAL STEM KWS ENCORE MEDICAL, L.P. 454G1062

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention 520-50-018,LOT 929C1046| 520-01-250,LOT 193G1079