BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COONRAD-MORREY HUMERAL COMPONENT

    MDR report key: 6313160 · Received February 8, 2017

    Report

    Report Number
    0001822565-2017-00639
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANSAT ET AL. "TOTAL ELBOW ARTHROPLASTY FOR ACUTE DISTAL HUMERAL FRACTURES IN PATIENTS OVER 65 YEARS OLD - RESULTS OF A MULTICENTER STUDY IN 87 PATIENTS." ORTHOPAEDICS AND TRAUMATOLOGY: SURGERY AND RESEARCH (2013) 99:779-784. 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 P. MANSAT, H. NOUAILLE DEGORCE, N. BONNEVIALLE, H. DEMEZON, T. FABRE AND SOFCOT INVOLVING THE HOSPITALS (B)(6).

    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 POST-OPERATIVE RADIOGRAPHS REVEALED TWENTY-ONE PATIENTS EXPERIENCED HUMERAL RADIOLUCENCY SIX TO ONE-HUNDRED-SIX MONTHS FOLLOWING ELBOW ARTHROPLASTY, WITH TWO APPEARING TO BE PROGRESSIVE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93729 UNKNOWN COONRAD-MORREY HUMERAL COMPONENT ELBOW ARTHROPLASTY JDC ZIMMER, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other