BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLIFIX 1G

    MDR report key: 21354708 · Received February 11, 2025

    Report

    Report Number
    3003854593-2025-00003
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 16, 2025
    Report Date
    February 7, 2025
    Manufacturer
    TEKNIMED SAS
    Product Code
    MBB
    PMA / PMN Number
    K242216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF DEVICE HISTORY RECORD: THE DEVICE HISTORY RECORD OF THE CEMENT LOT: 041G24132 HAS BEEN REVIEWED, WITH ALL CONTROLS COMPLIANT WHICH WERE PERFORMED DURING MANUFACTURING. THOSE CONTROLS INCLUDED: POWDER COMPONENTS' SPECIFICATIONS, LIQUID COMPONENTS' SPECIFICATIONS, CONTROLS PERFORMED ON THE FINAL CEMENT (DOUGHING TIME, SETTING TIME, INTRUSION, COMPRESSION, FLEXURAL STRENGTH AND MODULUS). LOT: 041G24132 IS COMPLIANT REVIEW OF SALES: (B)(4) UNITS HAVE BEEN SOLD WORLDWIDE BETWEEN SEPTEMBER AND NOVEMBER 2024. THIS IS THE FIRST COMPLAINT OF IT'S KIND RECEIVED. REVIEW OF CASE: NO SURGERY REPORT HAS BEEN RECEIVED DESPITE SEVERAL REQUESTS ON 21-JAN-2025 AND 28-JAN-2025 BY EMAIL. NO FURTHER INFORMATION OTHER THAN THAT WHICH WAS IN THE INITIAL REPORT HAS BEEN RECEIVED. INSTRUCTIONS FOR USE TF4104D1 IND7 CLEARLY STATES, "WARNING AND PRECAUTIONS FOR USE: PRIOR TO THE APPLICATION OF BONE CEMENT TO THE BONE, THE CAVITY SHOULD BE THOROUGHLY CLEANED, WASHED AND DRIED TO PREVENT CONTAMINATION BY BLOOD OR MARROW". THE DISTRIBUTOR WROTE THAT THERE WAS SOME FLUID BETWEEN THE BONE AND THE CEMENT WHICH WAS FLOWING CONTINUOUSLY, PREVENTING THE BONE FROM BEING DRY. THUS, THE PRECAUTIONS FOR USE WERE NOT ADHERED TO, PREVENTING THE CEMENT FROM HOLDING TO THE BONE. CONCLUSION: ROOT CAUSE: THERE WAS SOME FLUID BETWEEN THE BONE AND THE CEMENT WHICH WAS FLOWING CONTINUOUSLY WHICH PREVENTED THE BONE FROM BEING DRY AND WHICH PREVENTED THE CEMENT FROM HOLDING TO THE BONE. THE IFU WAS NOT FOLLOWED.

    Description of Event or Problem · 0

    THE CEMENT AMPLIFIX 1G WAS NOT HOLDING TO THE BONE, BUT THE CEMENT WAS HOLDING TO THE IMPLANT. THE PROCEDURE WAS A SURGICAL REVISION. THERE WAS A LOT OF FLUID COMING UP FROM THE TIBIAL BONE, WITH FLUID FLOWING CONTINUOUSLY BETWEEN THE BONE AND THE CEMENT PREVENTING THE BONE FROM BEING DRY. AMBIENT TEMPERATURE IN THE OPERATING ROOM WAS 17 DEGREES C. THE TEMPERATURE WAS INCREASED TO 19 DEGREES C AND THE PATIENT'S BLOOD PRESSURE WAS DECREASED TO LIMIT THE FLUID FLOW. THERE WAS NO EXTENSION TO APPLY PRESSURE DURING THE HARDENING PHASE. THE PROTHESIS USED WAS A TITANIUM ALLERGY KNEE PROSTHESIS FROM THE MANUFACTURER BIOIMPIANTI: KMOD PS FIXED ANTI-ALLERGY PLATE. THE SURGERY WAS DELAYED FOR MORE THAN ONE HOUR. THERE WAS NO CLINICAL OR MECHANICAL IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684608 AMPLIFIX 1G SURGICAL CEMENT WITH GENTAMICIN MBB TEKNIMED SAS 1-0400201 041G24132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention