BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURON SHOULDER

    MDR report key: 5994771 · Received October 3, 2016

    Report

    Report Number
    1644408-2016-00720
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 7, 2016
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    UDI-DI
    00888912145060
    PMA / PMN Number
    K080402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO CONVERT FROM A TURON SYSTEM TO A REVERSE SHOULDER PROSTHESIS (RSP). NO REASON WAS PROVIDED FOR THE NEED OF THE CONVERSION. THE IN-VIVO LENGTH OF SERVICE FOR THE PATIENT'S IMPLANT WAS 2.6 YEARS. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THE HEALTHCARE PROFESSIONAL INDICATED 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 (B)(4) FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) REVEALED NO DISCREPANCIES OR ISSUES WITH THE MANUFACTURING OF THIS PART. ALL CRITICAL DIMENSIONS AND SPECIFICATIONS IN EFFECT AT THE TIME THE PART WAS MANUFACTURED WERE MET. THE PRODUCT COMPLAINT REPORT HISTORY WAS REVIEWED AND NO TRENDS OR ON-GOING ISSUES WERE DEEMED AS PRESENT OR IN NEED OF REVIEW. THIS EVENT IS DEEMED TO BE NON-PRODUCT RELATED. THE ROOT CAUSE FOR THE CONVERSION WAS NOT REPORTED. THE SCOPE OF THIS INVESTIGATION IS LIMITED WITHOUT HAVING THE PARTS AVAILABLE TO (B)(4) FOR EVALUATION. OTHER CONDITIONS, ROOT CAUSE, RELATING TO THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE. INVENTORY CONTAINMENT IS NOT REQUIRED AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE SURGEON DECIDING TO CONVERT FROM A TURON SHOULDER TO REVERSE SHOULDER PROSTHESIS (RSP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646262 TURON SHOULDER GLENOID, KEELED, 46MM KWS ENCORE MEDICAL, L.P. 898C1011 00888912145060

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention