BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 6005748 · Received October 6, 2016

    Report

    Report Number
    1644408-2016-00740
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 2016
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    UDI-DI
    00888912024747
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS THE PATIENT FRACTURED THE GLENOID. THE SURGEON HAD NOTICED A POSSIBLE FRACTURE AT THE ORIGINAL SURGERY. THE SURGEON BELIEVED BY PUTTING IN A BASEPLATE AND SECURING IT WITH SCREWS WOULD HOLD THE BONE TOGETHER. THE SURGEON REMOVED ALL THE PARTS EXCEPT THE STEM AT THIS SURGERY. THERE WAS NO GLENOID STRUCTURE LEFT SO THE SURGEON CONVERTED THE PATIENT'S SHOULDER TO A HEMI SHOULDER SYSTEM. THE SURGEON PERFORMED THIS REVISION TO REMEDY THE PATIENT'S CONDITION. THE IN-VIVO LENGTH OF SERVICE FOR THE PATIENT'S IMPLANT WAS 2.5 MONTHS. 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 (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 SURGERY HAS BEEN DETERMINED TO BE NON-PRODUCT RELATED. THE ROOT CAUSE OF THIS EVENT WAS THE PATIENT FELL AND FRACTURED THE GLENOID. INVENTORY CONTAINMENT IS NOT REQUIRED SINCE 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 PATIENT FALLING AND FRACTURING HER GLENOID. THE SURGEON NOTICED A POSSIBLE FRACTURE ON ORIGINAL SURGERY, BUT THOUGHT PUTTING THE BASEPLATE AND SCREWS IN MIGHT KEEP IT TOGETHER. SURGEON REMOVED ALL PARTS EXCEPT THE STEM. THERE WAS NO GLENOID AT ALL AFTER REMOVAL. THE ONLY OPTION REMAINING WAS TO CONVERT TO A HEMI; THE SURGEON REMOVED THE SOCKET INSERT FROM THE ALTIVATE STEM IN ORDER TO PLACE THE HEMI ADAPTER AND A TURON NEUTRAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657013 RSP SHOULDER BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM KWS ENCORE MEDICAL, L.P. 866C2133 00888912024747

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 506-03-118,LOT 832C1234| 506-03-122,LOT 833C1239| 508-00-032,LOT 855C2030| 508-32-104,LOT 866C2133