BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY ELBOW

    MDR report key: 6143152 · Received December 2, 2016

    Report

    Report Number
    1644408-2016-00903
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 2, 2016
    Report Date
    January 7, 2017
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDC
    UDI-DI
    00888912225175
    PMA / PMN Number
    K013042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WAS SUBMITTED FOR THE SECOND STAGE OF A TWO STAGE PROCESS TO ALLEVIATE A CUSTOMER INFECTION. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2016. THE FIRST SURGERY OF THE TWO STAGE INFECTION TREATMENT WAS PERFORMED ON (B)(6) 2016 AND THE SECOND STAGE WAS PERFORMED (B)(6) 2016. REFER TO (B)(4) FOR THE RECORD OF THE FIRST STAGE OF THE TREATMENT AND DEVICE HISTORY. ON (B)(6) 2016 THE INFECTION CLEARED UP AND A NEW DISCOVERY ELBOW, DTICKET NO. (B)(4), WAS IMPLANTED IN THE PATIENT. THIS EVENT WAS DETERMINED TO BE A NON PRODUCT RELATED EVENT AND IS CONSIDERED A EVENT NOT CAUSED OR CREATED BY A DJO PRODUCT. THE ROOT CAUSE FOR THIS INVESTIGATION IS THE DEVELOPMENT OF A PATIENT INFECTION AND THE SURGEON'S PROCESS TO ADDRESS AND ALLEVIATE THE INFECTION. THE DISCOVERY ELBOW, REFENCE (B)(4), WAS REMOVED ON (B)(6) 2016 (B)(4). THIS EVENT REPORTS THE SECOND STAGE OF THE PROCESS AFTER THE INFECTION CLEARED UP. INVENTORY CONTAINMENT IS NOT REQUIRED AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON PREFORMED A TOTAL ELBOW REPLACEMENT ON (B)(6) 2016 USING THE DISCOVERY ELBOW. ON (B)(6) 2016 THE ELBOW BECAME INFECTED, ONLY THE ULNA WAS REMOVED AND THE ELBOW WAS CLEANED OUT. THE INFECTION CLEARED AND A NEW POLY WAS IMPLANTED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793427 DISCOVERY ELBOW DISC ULNA 3X115MM RT W/BRNG C JDC ENCORE MEDICAL, L.P. 452760 00888912225175

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention