BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 6011004 · Received October 7, 2016

    Report

    Report Number
    1644408-2016-00751
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    UDI-DI
    888912024815
    PMA / PMN Number
    K100741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS THIRD REVISION SURGERY WAS THE HUMERAL STEM HAD LOOSENED. THE IN-VIVO LENGTH OF SERVICE FOR THE PATIENT'S IMPLANT WAS 1.6 YEARS. 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 EVENT IS DEEMED TO BE NON-PRODUCT RELATED. THE ROOT CAUSE FOR THE STEM LOOSENING WAS REPORTED AS THE RESULT OF A CAR WRECK. 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 PATIENT BEING IN A CAR ACCIDENT AND HAVING HUMERAL STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662759 RSP SHOULDER RSP, PRIMARY HUMERAL MONOBLOCK, 8MM X 108 KWS ENCORE MEDICAL, L.P. 979F1109 888912024815

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 508-01-444,LOT 925F1000| 510-08-000,LOT 142G1073