BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACO'S BONE CEMENT

    MDR report key: 12143228 · Received July 8, 2021

    Report

    Report Number
    MW5102421
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    August 11, 2016
    Report Date
    July 7, 2021
    Manufacturer
    HERAEUS MEDICAL LLC
    Product Code
    HRY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TOTAL KNEE REPLACEMENT FROM (B)(6) 2016 CAME LOOSE USING PALACOS CEMENT & SMITH & NEPHEW JOURNEY II FROM TIBIA AND HAD TO BE REVISED ON (B)(6) 2021. I ALSO KNOW THAT THERE HAVE BEEN MANY OTHERS THAT HAVE HAD THE SAME ISSUES USED FROM SAME ORTHOPEDIC FACILITY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035036 PALACO'S BONE CEMENT BONE CEMENT HRY HERAEUS MEDICAL LLC
    1035037 SMITH & NEPHEW JOURNEY II PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HRY SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention