BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN COONRAD-MORREY TOTAL ELBOW

    MDR report key: 6333139 · Received February 15, 2017

    Report

    Report Number
    0001822565-2017-00825
    Event Type
    Death
    Date Received
    February 15, 2017
    Report Date
    January 16, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENT MENTIONED IN THE JOURNAL ARTICLE. 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. DATE OF DEATH - NI, DATE OF EVENT - NI, DEVICE CODE - NI, EXPIRATION DATE - NI, DATE IMPLANTED - NI, DATE EXPLANTED - NI, INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY N. PRASAD, A. ALI, AND D. STANLEY, MANUFACTURE DATE ¿ NI, THIS IS 4 OF 4 REPORTS BEING FILED FOR THE SAME JOURNAL ARTICLE (REFERENCE 1822565-2017-00822 / 00823 / 00824 / 00825).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "TOTAL ELBOW ARTHROPLASTY FOR NON-RHEUMATOID PATIENTS WITH A FRACTURE OF THE DISTAL HUMERUS: A MINIMUM TEN-YEAR FOLLOW-UP" WHICH AIMED TO TREAT PATIENTS WITH DISTAL HUMERUS FRACTURE USING THE COONRAD-MORREY ELBOW ARTHROPLASTY, MANUFACTURED BY ZIMMER. PATIENTS WERE IDENTIFIED IN THE ARTICLE THAT UNDERWENT ELBOW ARTHROPLASTY ON AN UNKNOWN DATE. ONE PATIENT WAS IDENTIFIED TO HAVE DIED LESS THAN 10 YEARS AFTER SURGERY AND EXPERIENCED SYMPTOMATIC HETEROTOPIC OSSIFICATION. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115969 UNKNOWN COONRAD-MORREY TOTAL ELBOW PROSTHESIS, ELBOW JDC ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death