BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    STIMULAN RAPIDCURE

    MDR report key: 21880579 · Received April 22, 2025

    Report

    Report Number
    9617083-2025-01127
    Event Type
    Injury
    Date Received
    April 22, 2025
    Date of Event
    March 24, 2025
    Report Date
    July 25, 2025
    Manufacturer
    BIOCOMPOSITES LTD
    Product Code
    MQV
    PMA / PMN Number
    K141830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A DAIR PROCEDURE OF A FEMORAL PLATING WHERE THE PLATE WAS COATED IN STIMULANT ON THE (B)(6). IN TOTAL 80CC WERE USED. THE SURGEON WAS REMINDED TO CHECK THE CALCIUM LEVELS OF THE PATIENT ON THE (B)(6). ON THE (B)(6) A MESSAGE WAS RECEIVED TO SAY THAT THE PATIENT DID EXPERIENCE RAISED CALCIUM LEVELS AND THEY HAD TO REMOVE THE STIMULANT IN A SEPARATE PROCEDURE AND THE PATIENT IS NOW DOING WELL.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A DAIR PROCEDURE OF A FEMORAL PLATING WHERE THE PLATE WAS COATED IN STIMULAN ON THE 12TH MARCH. IN TOTAL 80CC WERE USED. THE SURGEON WAS REMINDED TO CHECK THE CALCIUM LEVELS OF THE PATIENT ON THE 13TH MARCH. ON THE 24TH MARCH A MESSAGE WAS RECEIVED TO SAY THAT THE PATIENT DID EXPERIENCE RAISED CALCIUM LEVELS AND THEY HAD TO REMOVE THE STIMULAN IN A SEPARATE PROCEDURE AND THE PATIENT IS NOW DOING WELL. DUE TO THE LACK OF PROVIDED INFORMATION, A BMR REVIEW CANNOT BE CONDUCTED. HYPERCALCEMIA IS REFERENCED IN THE IFU PROVIDED AS A POSSIBLE ADVERSE EFFECT. IT HAS BEEN CONFIRMED THAT 80C OF STIMULAN RAPID CURE (20CC X 4) WAS USED DURING THE SURGERY WHICH IS FOUR TIMES OUR HIGHEST PRODUCT SIZE THEREFORE THE RISK OF HYPERCALCEMIA WILL HAVE BEEN COMPOUNDED. A TRUE ROOT CAUSE CANNOT BE IDENTIFIED FOR THIS EVENT DUE TO THE LACK OF INFORMATION REGARDING THE PRODUCT USED AND ALSO THE PATIENT DETAILS PRIOR TO AND FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239537 STIMULAN RAPIDCURE STIMULAN MQV BIOCOMPOSITES LTD 20CC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization