BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURON SHOULDER

    MDR report key: 2931652 · Received January 24, 2013

    Report

    Report Number
    1644408-2013-00039
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K080402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS A ROTATOR CUFF FAILURE AFTER EIGHT 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 NOT RETURNED 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 SHOWS THIS IS THE FOURTH COMPLAINT FOR THIS PART NUMBER: ONE DUE TO TRAUMA, ONE FOR INSTABILITY, ONE DUE TO INFECTION, AND ONE FOR DISLOCATION. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE ROTATOR CUFF FAILURE WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. 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'S ROTATOR CUFF FAILED WITH A TOTAL SHOULDER ARTHROPLASTY. THE SURGEON IMPLANTED A REVERSE SHOULDER PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34444 TURON SHOULDER PRIMARY HUMERAL STEM KWS ENCORE MEDICAL, L.P. 455G1048

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 520-01-250, LOT 193G1021| 520-00-000, LOT 878C1033| 520-50-022, LOT 54000045