BEUDAMED
    FDA Adverse Event Death Summary report: N

    BONE CEMENT

    MDR report key: 21833609 · Received April 14, 2025

    Report

    Report Number
    MW5168977
    Event Type
    Death
    Date Received
    April 14, 2025
    Date of Event
    April 1, 2025
    Report Date
    April 10, 2025
    Manufacturer
    ZIMMER BIOMET INC.
    Product Code
    LOD
    UDI-DI
    04040029922385
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SUBJECT ID: (B)(6). STUDY NO: DSJ-2016-03. CLINICAL ADVERSE EVENT RECEIVED FOR DEATH - CAUSE UNKNOWN. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE LOCATION: LEFT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116137 BONE CEMENT BONE CEMENT LOD ZIMMER BIOMET INC. 4712500398-3 AW21CC1005 04040029922385

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death