BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 5/10MM

    MDR report key: 22803880 · Received August 14, 2025

    Report

    Report Number
    3012523063-2025-00078
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    July 18, 2025
    Report Date
    May 22, 2026
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    JWH
    PMA / PMN Number
    K234044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE IMPLANTCAST GMBH THAT AN ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 5/10 MM COULD NOT BE CONNECTED WITH THE CORRESPONDING TIBIAL COMPONENT DURING THE IMPLANTATION SURGERY. ALTERNATIVELY, ANOTHER PE-INSERT (SZ. 5/12 MM) HAD TO BE USED AND THE IMPLANTATION COULD BE SUCCESSFULLY COMPLETED WITH AN EXTENSION OF THE SURGERY TIME BY APPROXIMATELY 15 MIN. OPTICAL EXAMINATION OF THE PE-INSERT IN QUESTION IS NOT POSSIBLE, AS IT WAS NOT PROVIDED TO THE IMPLANTCAST GMBH. HOWEVER, IT IS KNOWN FROM INTERNAL STUDIES AND PREVIOUS INCIDENTS THAT A DEFORMATION OF THE SNAP-IN EDGES AT THE BOTTOM OF THE PE INSERT OCCURS, WHEN IT IS NOT INSERTED CORRECTLY FROM ANTERIOR INTO THE TIBIAL COMPONENT BEFORE IMPACTION, AS IT IS STATED IN THE CORRESPONDING SURGICAL TECHNIQUE. DUE TO THIS DEFORMATION, IT IS NO LONGER POSSIBLE TO ENGAGE THE PE INSERT IN THE DOVETAIL OF THE TIBIAL COMPONENT. SINCE THIS ERROR PATTERN IS KNOWN TO CAUSE THE EXACT PROBLEM DESCRIBED AND ANOTHER DEVICE COULD BE INSERTED IN THE TIBIAL TRAY WITHOUT ANY PROBLEMS, A USE ERROR IS VERY LIKELY. THE MANUFACTURING DOCUMENTS, INSTRUCTIONS FOR USE AND DESCRIPTION OF THE SURGICAL TECHNIQUE WERE CHECKED AND NO DEVIATIONS WERE FOUND. IN CONCLUSION, THE AVAILABLE DATA INDICATE THAT THE INCIDENT WAS NOT CAUSED BY A DEFECTIVE PRODUCT, BUT BY INAPPROPRIATE APPLICATION BY THE SURGEON. THE INCIDENT WAS ASSIGNED TO THE ERROR PATTERN "INCOMPATIBILITY" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "THE ITEM 4245-4510 DIDN'T FITS TOGETHER TIBIA. ALL STEP TO ENSURE TIBIA AND INSERT ARE CLEAN HAVE BEEN PERFORMED." "TODAY IN THE ROOM WE HAD PROBLEMS WITH THE FB+ PS 5/10 INSERT (4245-4510 LOT (B)(6) ARRIVED WITH YOUR BILL NO.175 OF 18-3-25) AS IT WOULD NOT FIT. WE USED THE FB PS 5/12.5 INSERT AND HAD NO PROBLEMS. PLEASE ASK IF YOU HAVE HAD ANY OTHER REPORTS OF THIS ? THANK YOU VERY MUCH ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172094 ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 5/10MM PE-INSERT JWH IMPLANTCAST GMBH 42454510

    Patients

    Seq Age Sex Outcome Treatment
    1