BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURON SHOULDER

    MDR report key: 3161878 · Received June 6, 2013

    Report

    Report Number
    1644408-2013-00318
    Event Type
    Other
    Date Received
    June 6, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 25, 2013
    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 IDENTIFIED AS A ROTATOR CUFF TEAR AFTER 21 DAYS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. 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 BY THE HOSPITAL AND 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 RECORDS SHOWS THIS IS THE 14TH COMPLAINT FOR THIS PRODUCT: ONE DUE TO INCORRECT FEATURES, THREE DUE TO DISLOCATION, ONE DUE TO INFECTION, THREE DUE TO TRAUMA, AND SIX FOR STABILITY/POOR JOINT. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE ROTATOR CUFF TEAR WAS MOST LIKELY DUE TO THE PATIENT FALLING. THE INFORMATION REVIEWED SHOWED THE PRODUCT USED IN THE SURGERY MET ALL DESIGN, MATERIAL, AND MANUFACTURING SPECIFICATIONS. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD A POST OPERATIVE FALL THAT RESULTED IN A ROTATOR CUFF TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251913 TURON SHOULDER HUMERAL NECK, NEUTRAL KWS ENCORE MEDICAL, L.P. 878C1202

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 520-50-118: LOT: 934C1024