BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURON SHOULDER

    MDR report key: 3180045 · Received June 13, 2013

    Report

    Report Number
    1644408-2013-00333
    Event Type
    Other
    Date Received
    June 13, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 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 TO REMEDY THE PATIENT'S FAILED SUBSCAPULAR TENDON AFTER 1.2 YEARS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. 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 SHOWS THIS IS THE FIRST COMPLAINT FOR THIS PRODUCT. THE ROOT CAUSE FOR THE FAILED SUBSCAPULAR TENDON COULD NOT BE DETERMINED WITH CONFIDENCE. THE INFORMATION REPORTED SHOWED THAT THE PRODUCT MET ALL DESIGN, MATERIAL, AND MANUFACTURING SPECIFICATIONS. THERE IS NO INDICATION OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT RECENTLY HAD A TURON TOTAL SHOULDER REVISION. AFTER A SUCCESSFUL SURGERY, THE PT PRESENTED BACK WITH A FAILED SUBSCAP TENDON AND INSTABILITY. THE SURGEON DECIDED IT WAS BEST TO CONVERT TO A REVERSE SHOULDER PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269851 TURON SHOULDER STANDARD HUMERAL HEAD KWS ENCORE MEDICAL, L.P. 53982033

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention (B)(4), LOT 533G1014