BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKOWN EXTREMITY

    MDR report key: 6922386 · Received October 6, 2017

    Report

    Report Number
    0001825034-2017-08118
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Report Date
    October 6, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MJT
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. PRODUCT NOT CLEARED IN THE US. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY, NEITHER WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICAL PATIENT HAD A RIGHT SHOULDER PROCEDURE ON (B)(6) 2014. INFORMATION WAS RECEIVED FROM THE SURGEON THAT STATED THAT THE PATIENT'S JOINT WAS "OVERSTUFFED" WHICH ACCORDING TO A DESIGN ENGINEER CAN CAUSE PROBLEMS FOR THE PATIENT. NO REVISION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705341 UNKOWN EXTREMITY PROSTHESIS - SHOULDER MJT ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1