BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE HUMERAL SHOULDER STEM

    MDR report key: 6058050 · Received October 26, 2016

    Report

    Report Number
    1644408-2016-00809
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    September 26, 2016
    Report Date
    December 13, 2016
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    PHX
    UDI-DI
    00888912168489
    PMA / PMN Number
    K141990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS DEVICE LOOSENING. THE PREVIOUS SURGERY AND THE REVISION DETAILED IN THIS INVESTIGATION OCCURRED 49 DAYS APART. 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 (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 DEVICE LOOSENING WAS NOT REPORTED. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO THE REPORTED "NON FIXATION LOOSE STEM" THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. THE SCOPE OF THIS INVESTIGATION IS LIMITED WITHOUT HAVING THE PARTS AVAILABLE TO DJO SURGICAL 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 NON FIXATION, LOOSE STEM. THE SURGEON REMOVED ALL OF THE COMPONENTS AND PUT IN A ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708232 ENCORE HUMERAL SHOULDER STEM ENCORE REVERSE SHOULDER HUMERAL STEM, PRIMARY, 42MM SHELL, SZ 14X108MM PHX ENCORE MEDICAL, L.P. 415T1019 00888912168489

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention 506-03-114,LOT 831C1286| 506-03-114,LOT 831C1316| 506-03-126,LOT 834C1273| 506-03-134,LOT 836C1115| 508-32-104,LOT 866C2142| 508-36-101,LOT 869C1909| 509-00-036,LOT 378P1035