BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN HEAD

    MDR report key: 10282693 · Received July 16, 2020

    Report

    Report Number
    0001825034-2020-02767
    Event Type
    Death
    Date Received
    July 16, 2020
    Date of Event
    January 14, 2020
    Report Date
    August 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDB
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONSIDERED CONFIRMED AS THE X-RAYS SHOWED LOOSENING OF THE RADIAL HEAD WITH DISSOCIATED SCREW AS WELL AS A SMALL FRACTURE THROUGHOUT THE RADIUS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05821.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). (UDI): N/A. MEDICAL PRODUCT: CATALOG #: 11-210063, EXPLOR 8X28MM IMPL STEM W/SCR, LOT # 543210. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLOR ELBOW ARTHROPLASTY APPROXIMATELY 10 YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED ABOUT 2 MONTHS AGO DUE TO THE LOCKING SCREW BACKING OUT, PAIN, TISSUE DAMAGE, AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747251 UNKNOWN HEAD PROSTHESIS ELBOW JDB ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R