BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURON SHOULDER

    MDR report key: 3790898 · Received May 5, 2014

    Report

    Report Number
    1644408-2014-00267
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 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

    DISPOSED OF.

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS A TORN ROTATOR CUFF, TRAUMA, AFTER 4.7 MONTHS OF PATIENT USE. 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 FOR THIS PART FROM THIS LOT. THE ROOT CAUSE FOR THE TORN ROTATOR CUFF, TRAUMA, WAS REPORTED AS A FALL. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT FALLING AND TEARING THEIR ROTATOR CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266904 TURON SHOULDER TURON ALL-POLY KEELED GLENOID 50MM KWS ENCORE MEDICAL, L.P. 193G1066

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 520-50-018, LOT 929C1025| 520-00-000, LOT 878C1289