BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COONRAD-MORREY IMPLANT

    MDR report key: 6330009 · Received February 14, 2017

    Report

    Report Number
    0001822565-2017-00772
    Event Type
    Injury
    Date Received
    February 14, 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
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLASCHKE ET AL. REVISION TOTAL ELBOW ARTHROPLASTY WITH THE LINKED COONRAD-MORREY TOTAL ELBOW ARTHROPLASTY: A RETROSPECTIVE STUDY OF TWENTY PROCEDURES." INTERNATIONAL ORTHOPAEDICS (SICOT)(2013). 37:853-858 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 FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. WEIGHT ¿ NI, DATE OF EVENT - NI, EXPIRATION DATE - NI, DATE IMPLANTED - NI, DATE EXPLANTED - NI, INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY HANS CHRISTIAN PLASCHKE, THEIS THILLEMANN, ANNE KATHRINE BELLING-SORENSEN AND BO OLSEN., MANUFACTURING DATE ¿ NI.

    Description of Event or Problem · 1

    IT IS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT UNDERWENT ELBOW ARTHROPLASTY REVISION DUE TO LOOSENING OF THE SPLINE AT NEARLY FIFTEEN YEARS FOLLOWING ELBOW ARTHROPLASTY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112375 UNKNOWN COONRAD-MORREY IMPLANT ELBOW PROSTHESIS JDC ZIMMER, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R