BEUDAMED
    FDA Adverse Event Death Summary report: N

    BETA-BSM

    MDR report key: 8348066 · Received February 18, 2019

    Report

    Report Number
    0001225112-2019-00001
    Event Type
    Death
    Date Received
    February 18, 2019
    Date of Event
    January 29, 2019
    Report Date
    October 9, 2020
    Manufacturer
    ETEX CORPORATION
    Product Code
    MQV
    PMA / PMN Number
    K101557
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED NO ACTION IS NECESSARY AS NO TRENDS WERE IDENTIFIED. A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED. ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. THERE IS NO EVIDENCE OF PRODUCT NONCONFORMANCE AND IT DOES NOT APPEAR THAT THE CAUSE OF THE DEATH IS RELATED TO PRODUCT PERFORMANCE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER ETEX WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1; A4; B4; B5; G4; G7; H1; H2. ADDITIONAL INFORMATION DOES NOT CHANGE THE RESULTS OF THE PREVIOUS INVESTIGATION. 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

    DURING THE SURGERY PATIENT VITALS WERE IN CONCERN AND PATIENT DIED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER ETEX COMPLAINT NUMBER (B)(4) HAS BEEN INITIATED TO INVESTIGATE THE EVENT. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). CONCOMITANT MEDICAL PRODUCTS - BETA-BSM CATALOG#: 76-6016, LOT#: 102112, SERIAL#'S: (B)(4). THE DEVICE WAS LEFT IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A PROCEDURE FOR A BENIGN HUMERAL CYST. DURING INTER-OSSEOUS, THE PATIENTS VITALS BECAME UNSTABLE AND WAS TRANSFERRED TO A LEVEL 1 TRAUMA CENTER AND LATER EXPIRED. PER AN EMAIL FROM THE SURGEON, "THE MEDICAL EXAMINER DEFINED THE CAUSE OF DEATH AS LIKELY DUE TO ACUTE CEMENT EMBOLISM SYNDROME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141539 BETA-BSM INJECTABLE BONE SUBSTITUTE MATERIAL MQV ETEX CORPORATION N/A 102112

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death SEE H10 NARRATIVE