BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COONRAD-MORREY ULNAR COMPONENT

    MDR report key: 6311893 · Received February 8, 2017

    Report

    Report Number
    0001822565-2017-00610
    Event Type
    Injury
    Date Received
    February 8, 2017
    Report Date
    February 6, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MORREY ET AL. "IS COONRAD-MORREY TOTAL ELBOW ARTHROPLASTY A VIABLE OPTION FOR TREATMENT OF DISTAL HUMERAL NONUNIONS IN THE ELDERLY?" JOURNAL TITLE. 49(4):354-360. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE DEVICE IS UNKNOWN. DEVICE HISTORY RECORDS CANNOT BE REVIEWED SINCE THE LOT NUMBER IS UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. PRODUCT HISTORY SEARCH CANNOT BE COMPLETED SINCE THE LOT NUMBER IS UNKNOWN. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE ARTICLE WAS WRITTEN BY ALI ERSEN, MEHMET DEMIRHAN, ATA CAN ATALAR, TEOMAN ATICI AND MEHMET KAPICIOGLU INVOLVING THE HOSPITALS ISTANBUL UNIVERSITY ISTANBUL FACULTY OF MEDICINE, KOC UNIVERSITY SCHOOL OF MEDICINE AND ULUDAG UNIVERSITY FACULTY OF MEDICINE, TURKEY.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. ZIMMER BIOMET BECAME AWARE OF THE REPORTED EVENT ON JANUARY 16, 2017, RATHER THAN JANUARY 17, 2017 AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    IT IS REPORTED IN A JOURNAL ARTICLE THAT TWO PATIENTS EXPERIENCED NON-PROGRESSIVE RADIOLUCENT LINES AROUND ULNAR COMPONENTS FOLLOWING ELBOW ARTHROPLASTY SIXTY-THREE TO EIGHTY-FOUR MONTHS POST-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94166 UNKNOWN COONRAD-MORREY ULNAR COMPONENT ELBOW PROSTHESIS JDC ZIMMER, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other