BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOSPHERE FORCEPS

    MDR report key: 8658116 · Received May 31, 2019

    Report

    Report Number
    0001825034-2019-02400
    Event Type
    Injury
    Date Received
    May 31, 2019
    Report Date
    May 31, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HYA
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CANNOT BE CONFIRMED BASED ON THE LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02177.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING SURGERY, THE GLENOSPHERE INSERTER FRACTURED AND THE FRACTURED PIECE RETAINED INSIDE PATIENT'S BODY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452244 GLENOSPHERE FORCEPS CHISEL, SURGICAL HYA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other