BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL BEARING COMPONENT

    MDR report key: 7011382 · Received November 8, 2017

    Report

    Report Number
    0001825034-2017-09816
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    July 6, 2017
    Report Date
    October 31, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MJT
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS-HUMERAL HEAD. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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:0001825034-2017-09817.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION DUE TO DISLOCATION. DURING THE REVISION SURGERY A NEW STEM WAS INSERTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790416 UNKNOWN HUMERAL BEARING COMPONENT PROSTHESIS, SHOULDER MJT ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R