BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS®

    MDR report key: 22352636 · Received June 30, 2025

    Report

    Report Number
    22352636
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 22, 2025
    Report Date
    June 20, 2025
    Manufacturer
    HERAEUS MEDICAL LLC
    Product Code
    MBB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    S [SITUATION]- PALACOS GENT PRO80 CEMENT SYSTEM FAILURE. B [BACKGROUND]- TOTAL KNEE BILATERAL PROCEDURE UNDER WAY AND WHILE CST [CERTIFIED SURGICAL TECHNOLOGIST] IS PREPARING CEMENT THE SYSTEM FAILED DEPLOY COMPLETELY INTO THE MIXING CHAMBER WITH CEMENT POWDER. A [ASSESSMENT]- DEFECTIVE ITEM/ SYSTEM/ PRODUCT- MIXING DIRECTION FOLLOWED. R [RECOMMENDATION]- REMOVED FROM STERILE SET UP/ FIELD; REPORTED TO CHARGE RN AND MATERIALS SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969957 PALACOS® BONE CEMENT, ANTIBIOTIC MBB HERAEUS MEDICAL LLC R+G PRO 80 9018162878

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown