BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMP PRIMARY STEM 10MM MINI

    MDR report key: 9540990 · Received January 2, 2020

    Report

    Report Number
    0001825034-2019-05819
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 10, 2019
    Report Date
    May 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    UDI-DI
    00880304449725
    PMA / PMN Number
    K060692
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: CATALOG #: 113629, COMP PRIMARY STEM 9MM MINI, LOT # 052830. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 DURING THE SHOULDER ARTHROPLASTY THE HUMERAL STEM WAS IMPLANTED AND IT WOULD NOT SEAT PROPERLY IN THE REAMED CANNEL. NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE EVENT. NO PATIENT IMPACT OR CONSEQUENCES ARE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001 COMP PRIMARY STEM 10MM MINI PROSTHESIS, SHOULDER HSD ZIMMER BIOMET, INC. N/A 018550 00880304449725

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO SEE H10 NARRATIVE