BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETEX BETA-BSM

    MDR report key: 8335509 · Received February 12, 2019

    Report

    Report Number
    MW5083932
    Event Type
    Death
    Date Received
    February 12, 2019
    Date of Event
    January 29, 2019
    Report Date
    February 8, 2019
    Manufacturer
    ZIMMER BIOMET/ETEX CORPORATION
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH DIAGNOSIS OF LEFT PROXIMAL HUMERAL CYST WITH PAIN. IMAGING INCLUDING AXIA IMAGING AND SCINTIGRAPHY WERE OBTAINED. THE PATIENT WAS COUNSELED THAT SHE WAS AT RISK FOR PATHOLOGICAL FRACTURE. PATIENT UNDERWENT FLUOROSCOPICALLY ASSISTED ASPIRATION AND INJECTED WITH ETEX BETA-BSM CEMENT (CALCIUM PRODUCT). A JAMSHIDI NEEDLE WAS USED FOR ASPIRATION OF THE CYSTS. BETA-BSM WAS PREPARED AND FOUR, 5ML PACKETS OF MATERIAL WAS SEQUENTIALLY INJECTED DIRECTIONALLY INTO THE PROXIMAL HUMERAL CYSTS USING INTRAOPERATIVE FLUOROSCOPY. PRIOR TO THE 5TH INJECTION, THE ANESTHESIOLOGIST NOTIFIED THE TEAM OF A PRECIPITOUS DROP IN THE PATIENT¿S BLOOD PRESSURE AND OXYGENATION. PATIENT EXPERIENCED AN ACUTE DROP IN ETCO2. THE PROCEDURE WAS ABORTED, AND RESUSCITATIVE MEASURES WERE INITIATED. DOSE OR AMOUNT: 5 ML; FREQUENCY: SINGLE APPLICATION; ROUTE: INTRA=OSSEOUS. DOSE OR AMOUNT: 5 ML; FREQUENCY: SINGLE APPLICATION; ROUTE: INTRA-OSSEOUS. DIAGNOSIS OR REASON FOR USE: LEFT PROXIMAL HUMERAL BONE CYST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123171 ETEX BETA-BSM BONE GRAFTING MATERIAL SYNTHETIC MQV ZIMMER BIOMET/ETEX CORPORATION MQV (21 CFR 888.3045)
    123215 ETEX (BETA-BSM), 5 ML BONE GRAFTING MATERIAL SYNTHETIC MQV ZIMMER BIOMET/ETEX CORPORATION MQV (21 CFR 888.3045) 102112-0100
    123216 ETEX (BETA-BSM), 5 ML BONE GRAFTING MATERIAL SYNTHETIC MQV ZIMMER BIOMET/ETEX CORPORATION MQV (21 CFR 888.3045) 102112-0156
    123217 ETEX BETA-BSM BONE GRAFTING MATERIAL SYNTHETIC MQV ZIMMER BIOMET/ETEX CORPORATION MQV (21 CFR 888.3045)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death