BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 4/10MM

    MDR report key: 23474059 · Received November 5, 2025

    Report

    Report Number
    3012523063-2025-00091
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 5, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    JWH
    PMA / PMN Number
    K234044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE IMPLANT CAST GMBH THAT AN ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 4/10 MM COULD NOT BE CONNECTED WITH THE CORRESPONDING TIBIAL COMPONENT DURING THE IMPLANTATION SURGERY. ALTERNATIVELY, ANOTHER PE-INSERT OF THE SAME SIZE HAD TO BE USED, AND THE IMPLANTATION COULD BE SUCCESSFULLY COMPLETED WITH AN EXTENSION OF THE SURGERY TIME BY APPROXIMATELY 15 MIN. AN OPTICAL EXAMINATION OF THE PE-INSERT IN QUESTION IS NOT POSSIBLE, AS IT WAS DISCARDED AND THEREFORE NOT PROVIDED TO THE IMPLANTCAST GMBH AND NO PICTURES WERE PROVIDED EITHER. THE MANUFACTURING DOCUMENTS, INSTRUCTIONS FOR USE AND DESCRIPTION OF THE SURGICAL TECHNIQUE WERE CHECKED AND NO DEVIATIONS WERE FOUND. BASED ON THE AVAILABLE INFORMATION, NO FAILURE OF THE DESIGN OR DURING THE MANUFACTURING OF THE PE-INSERT COULD BE DETERMINED. IT CAN ONLY BE ASSUMED THAT A USER ERROR MAY HAVE CONTRIBUTED TO THE INCOMPATIBILITY. HOWEVER, SINCE THE PRODUCT IN QUESTION IS NOT AVAILABLE, THIS CAN NEITHER BE CONFIRMED NOR DENIED DUE TO LACK OF INFORMATION. SUCH A USER ERROR COULD EASILY BE SPOTTED DUE TO CHARACTERISTIC DEFORMATIONS ON THE PRODUCT. SINCE ANOTHER PE-INSERT COULD BE INSERTED WITHOUT A PROBLEM, A FAILURE ON THE TIBIA IS EXCLUDED. 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 IMPLANT CAST GMBH: "THE ITEM 4245-4410 LOT 2332137088 DIDN'T FITS TOGETHER TIBIA. ALL STEP TO ENSURE TIBIA AND INSERT ARE CLEAN HAVE BEEN PERFORMED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2688608 ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 4/10MM No Match JWH IMPLANTCAST GMBH 42454410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ACS® EXTENSION STEM MALE TAPER 14/35MM.| ACS® FB+ TIBIA CEMENTED SZ. 4 RIGHT INCL. PLUGS.| ACS® PE-PATELLA CEMENTED 32 MM.| ACS® PS FEMORAL COMPONENT CEMENTED SZ. 3 RIGHT.