BEUDAMED
    FDA Adverse Event Summary report: N

    TURON SHOULDER

    MDR report key: 3013420 · Received March 20, 2013

    Report

    Report Number
    1644408-2013-00167
    Date Received
    March 20, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 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 DUE TO A TORN ROTATOR CUFF 2.3 YEARS AFTER PRIOR SURGERY. 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 SECOND COMPLAINT FOR THIS PART NUMBER; TWO DUE TO TRAUMA. THE ROOT CAUSE FOR THE TORN ROTATOR CUFF WAS NOT DETERMINED WITH CONFIDENCE. 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 TORE HIS ROTATOR CUFF. THE SURGEON REMOVED THE GLENOID, HUMERAL HEAD, AND HUMERAL NECK AND CONVERTED THE PATIENT TO A REVERSE SHOULDER PROSTHESIS (RSP). THE ORIGINAL STEM WAS KEPT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114867 TURON SHOULDER ALL-POLY PEGGED GLENOID KWS ENCORE MEDICAL, L.P. 193G1000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention (B)(4), LOT 54003849| (B)(4), LOT A1000024