BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURON SHOULDER

    MDR report key: 4182226 · Received October 17, 2014

    Report

    Report Number
    1644408-2014-00647
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    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 THIS REVISION SURGERY WAS PERFORMED WAS TO REPAIR A SUBSCAPULARIS FAILURE AFTER THREE MONTHS OF PATIENT USE BY IMPLANTING A NEW PROSTHESIS. 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 DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THE MAIN CONTRIBUTOR COMPONENT LISTED IN THE COMPLAINT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT AGAINST LOT NUMBER 878C1363. (B)(4). THE PATIENT IS REPORTED TO HAVE SUFFERED A SUBSCAPULARIS FAILURE BUT NO INFORMATION WAS SUPPLIED THAT OFFERED A REASON OR ROOT CAUSE FOR THE FAILURE. 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 A SUBSCAPULARIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661884 TURON SHOULDER TURON HUMERAL NECK, NEUTRAL KWS ENCORE MEDICAL, L.P. 878C1363

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 520-01-246, LOT 192G1076| 520-01-010, LOT 455G1123| 520-46-016, LOT 917C1058