BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY ELBOW

    MDR report key: 6109788 · Received November 17, 2016

    Report

    Report Number
    1644408-2016-00899
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    June 20, 2016
    Report Date
    May 26, 2022
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10: ADDING CONCOMITANT PART 402283.

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS AN INFECTION. THE PREVIOUS SURGERY AND THE REVISION DETAILED IN THIS INVESTIGATION OCCURRED OVER 5.5 MONTHS APART. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE POSSIBLE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. 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 IMPLANT DEVICE HISTORY RECORDS (DHRS) AND PRODUCT COMPLAINT REPORT (PCR) DATABASE RECORDS SHOW THAT THE REPORTED COMPONENT USED IN THE PREVIOUS SURGERY MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NON-CONFORMING MATERIAL REPORTS (NCMRS) ASSOCIATED WITH THE PRODUCT THAT MAY HAVE CONTRIBUTED TO AN INFECTION. THE DEVICE WAS VERIFIED BY BIOMET (ZIMMER) INC. TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WAS WITHIN IT'S EXPIRATION DATE AT THE TIME OF USE DURING THE PREVIOUS SURGERY. THERE WERE NO FINDINGS DURING THIS INVESTIGATION THAT INDICATE THAT THE REPORTED DEVICE WAS THE ROOT CAUSE OR HAD A DIRECT CONNECTION WITH THE PATIENT'S INFECTION. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON PERFORMED 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762285 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 Male Required Intervention 402283 COBALT G-HV BONE CEMENT 40G 472280| 402283 COBALT G-HV BONE CEMENT 40G 472280| 402283 COBALT G-HV BONE CEMENT 40G 627540