BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLIFIX 1G

    MDR report key: 21251866 · Received January 28, 2025

    Report

    Report Number
    3003854593-2025-00002
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 14, 2025
    Manufacturer
    TEKNIMED SAS
    Product Code
    LOD
    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

    (B)(4) UNITS HAVE BEEN SOLD ALL OVER THE WORLD. THIS IS THE FIRST COMPLAINT RECEIVED. THE DEVICE HISTORY RECORD OF THE CEMENT LOG 041G24091 HAS BEEN REVIEWED, WITH ALL CONTROLS PERFORMED DURING MANUFACTURING DEMONSTRATING COMPLIANCE. (POWDER COMPONENTS' SPECIFICATIONS, LIQUID COMPONENTS' SPECIFICATIONS, CONTROLS PERFORMED ON THE FINAL CEMENT, INCLUDING: DOUGHING TIME, SETTING TIME, INTRUSION, COMPRESSION, FLEXURAL STRENGTH, MODULUS). NO SURGERY REPORT HAS BEEN RECEIVED. NO FURTHER INFORMATION THAN THE ONE PRESENT IN THE DESCRIPTION HAS BEEN RECEIVED. IT IS NOT POSSIBLE TO KNOW HOW THE CEMENT WAS STORED AND THEN PREPARED. THREE (3) UNITS OF THE CEMENT STORED BY THE HOSPITAL WILL BE RECEIVED AND ANALYSED BY TEKNIMED IN ORDER TO CONFIRM THE COMPLIANCE OF THE CEMENT. PERFORMING AN INVESTIGATION INTO THE IMPLANT WOULD ALSO BE IMPORTANT.

    Additional Manufacturer Narrative · 0

    REVIEW OF CASE: NO SURGERY REPORT HAS BEEN RECEIVED DESPITE REQUESTS BY EMAIL ON (B)(6) 2025. NO FURTHER INFORMATION THAN THE ONE PRESENT IN THE DESCRIPTION HAS BEEN RECEIVED. IT IS NOT POSSIBLE TO KNOW HOW THE CEMENT WAS STORED AND THEN PREPARED. ACCORDING TO US, IT WOULD BE IMPORTANT TO PERFORM SOME INVESTIGATIONS ALSO ON THE IMPLANT. FINAL REPORT: ON (B)(6) 2025, THE DISTRIBUTOR AMPLITUDE SENT BACK 3 UNITS OF THE SAME BATCH 041G24091. TEKNIMED PERFORMED SOME SETTING TIME TESTS ON (B)(6) 2025, THE RESULTS WERE IN ACCORDANCE WITH THE SPECIFICATIONS. NO SURGERY REPORT HAS BEEN RECEIVED DESPITE AN ADDITIONAL REQUEST BY EMAIL ON (B)(6) 2025. DUE TO LACK OF INFORMATION RECEIVED, IT IS NOT POSSIBLE TO PERFORM FURTHER INVESTIGATIONS. BASED ON THE SALES, REVIEW OF THE DHR AND RETESTS ON THE 3 UNITS OF THE SAME BATCH, WE CONFIRM THAT THE BATCH WAS RELEASED AS COMPLIANT AND THE EVENT WAS NOT RELATED TO THE CEMENT AMPLIFIX 1G BATCH 041G24091. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    THE HOSPITAL DECLARED THAT THEY USED 6 CEMENTS IN THE SAME OPERATION. THE CEMENT WOULD NOT HOLD ON THE FEMORAL IMPLANT. THE CEMENT STUCK TO THE BONE AND NOT TO THEM IMPLANT AFTER 10 MINUTES. THEY HAD TO CHANGE THE FEMORAL IMPLANT. THE DISTRIBUTOR AGENT WAS ABLE TO TEST PUTTING A PIECE OF CEMENT ON AN UNUSED IMPLANT. AFTER WAITING 25 MINUTES, THE CEMENT HAD HARDENED BUT WOULD NOT HOLD ON THE IMPLANT. THE SURGERY WAS DELAYED FOR ONE HOUR. THERE WAS NO OTHER IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376724 AMPLIFIX 1G BONE CEMENT WITH ANTIBIOTIC LOD TEKNIMED SAS 041G24091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention