BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER BIOMET REAMER

    MDR report key: 19250330 · Received May 3, 2024

    Report

    Report Number
    MW5154556
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    March 29, 2024
    Report Date
    April 30, 2024
    Manufacturer
    ZIMMER BIOMET / ZIMMER GMBH
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A SMALL, COUPLE MILLIMETER PIECE OF THE REAMER USED DURING PROCEDURE BROKE OFF IN THE INTRAMEDULLARY SPACE OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642693 ZIMMER BIOMET REAMER REAMER HTO ZIMMER BIOMET / ZIMMER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other