BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS MV+G

    MDR report key: 19926117 · Received August 7, 2024

    Report

    Report Number
    3006406161-2024-08071
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 14, 2023
    Report Date
    August 7, 2024
    Manufacturer
    HERAEUS MEDICAL GMBH
    Product Code
    MBB
    PMA / PMN Number
    K202475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING CEMENTED ARTHROPLASTY, AFTER THE CEMENT HAD CURED, THERE WAS NO ADHERENCE BETWEEN BONE CEMENT AND PROSTHESIS. THE CEMENT WAS REMOVED, AND THE PROSTHESIS WAS FIXED WITH ANOTHER CEMENT. IN GENERAL, THE BONDING ON THE BONE CEMENT - PROSTHESIS INTERFACE IS ESTABLISHED BY A COMBINATION OF FORM FIT AND FORCE FIT. BONE CEMENT IS NOT A GLUE; THE BONDING IS DEPENDENT ON INTERLOCKING AND CONNECTION BETWEEN THIS INTERFACE. THERE ARE SEVERAL FACTORS THAT HAVE AN INFLUENCE ON THE BONDING BETWEEN BONE CEMENT - PROSTHESIS, E.G.: - PREPARATION OF THE PROSTHESIS: AS WELL AS THE IMPLANTATION SITE, THE IMPLANTS SHOULD BE DRY AND CLEAN PRIOR TO THE CEMENT APPLICATION. CONTAMINATION WITH FAT, BLOOD OR BONE MARROW REDUCES THE ADHERENCE BETWEEN BONE CEMENT AND PROSTHESIS. - PROSTHESIS DESIGN: PROSTHESES FOR CEMENTED USE ARE DESIGNED DIFFERENTLY THAN PROSTHESES FOR UNCEMENTED USE. IF THE WRONG PROSTHESIS IS SELECTED, THIS CAN HAVE A NEGATIVE INFLUENCE ON THE CEMENT-PROSTHESIS ADHERENCE. - CEMENT APPLICATION: TO CREATE THE BEST ADHERENCE BETWEEN BONE- BONE CEMENT - PROSTHESIS, THE APPLICATION TIME FRAME OF THE CEMENT MUST BE ADHERED TO. IF THE CEMENT IS APPLIED TOO LATE IT REDUCES ITS ABILITY TO BOND WITH THE BONE/PROSTHESIS. FURTHERMORE, THE APPLICATION PRESSURE HAS AN INFLUENCE ON THE INTERFACE INTERLOCKING. - INSERTION OF THE PROSTHESIS: IF THE PROSTHESIS IS MOVED PRIOR TO THE BONE CEMENT BEING TOTALLY CURED THIS ALSO HAVE A NEGATIVE EFFECT ON THE BONDING BETWEEN CEMENT AND PROSTHESIS. BASED ON THE BATCH RECORD REVIEW NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. HOWEVER, THE BONE CEMENT WAS MIXED FOR ONE MINUTE INSTEAD OF 30 SECONDS. THIS CAN LEAD TO A SHORTENED APPLICATION TIME AND REDUCE THE FIXATION PROPERTIES OF THE BONE CEMENT TO THE KNEE PROSTHESIS. THE MIXING TIME OF 30 SECONDS IS CLEARLY DESCRIBED IN THE IFU ALONG WITH THE MIXING AND APPLICATION TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT KNEE REPLACEMENT. DURING THE OPERATION, THE BONE CEMENT WAS MIXED FOR ABOUT ONE MINUTE. WHEN THE BONE CEMENT NO LONGER ADHERES TO THE RUBBER GLOVES, IT WAS IMPLANTED INTO THE PATIENT. THE PROSTHESIS WAS THEN FITTED. AFTER THE BONE CEMENT WAS COOLED AND SOLIDIFIED, THE BONE CEMENT AND THE PROSTHESIS WERE STRATIFIED AND NON-STICK. THE BONE CEMENT COULD NOT FIX THE PROSTHESIS. PALACOS MV+G BONE CEMENT WAS REMOVED AND ANOTHER BRAND OF CEMENT WAS USED TO IMPLANTED THE PROSTHESIS. MIXING SYSTEM BONE CEMENT: HAND MIXING PREPARATION OF IMPLANTATION SITE: PULSE LAVAGE METHOD OF CEMENT APPLICATION: FINGER PACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220331 PALACOS MV+G BONE CEMENT, MEDICATED MBB HERAEUS MEDICAL GMBH 60261083

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention