BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COONRAD-MORREY IMPLANT

    MDR report key: 6331788 · Received February 15, 2017

    Report

    Report Number
    0001822565-2017-00764
    Event Type
    Injury
    Date Received
    February 15, 2017
    Report Date
    February 9, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIETZ ET AL. "FAILURE OF THE HINGE MECHANISM IN TOTAL ELBOW ARTHROPLASTY." J SHOULDER ELBOW SURG (2010). 19:368-375. 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. (B)(6).

    Description of Event or Problem · 1

    IT IS REPORTED IN A JOURNAL ARTICLE THAT TWO PATIENTS UNDERWENT ELBOW ARTHROPLASTY REVISION DUE TO GROSS INSTABILITY, CREPITUS AND DECREASED RANGE OF MOTION FOLLOWING ELBOW ARTHROPLASTY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113661 UNKNOWN COONRAD-MORREY IMPLANT ELBOW PROSTHESIS JDC ZIMMER, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R