BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 2/10MM

    MDR report key: 22847601 · Received August 20, 2025

    Report

    Report Number
    3012523063-2025-00080
    Event Type
    Injury
    Date Received
    August 20, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 20, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    JWH
    PMA / PMN Number
    K234044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE IMPLANTCAST GMBH THAT THE SURGEON WAS NOT ABLE TO FIT AN ACS® FB+ SC PE-INSERT INTO THE TIBIAL TRAY. THE AFFECTED IMPLANT HAS NOT BEEN MADE AVAILABLE YET. AS NEITHER THE IMPLANTS NOR INTRAOPERATIVE IMAGES WERE AVAILABLE, AN OPTICAL EXAMINATION COULD NOT BE PERFORMED. THE MANUFACTURING DOCUMENTS, INSTRUCTIONS FOR USE AND DESCRIPTION OF THE SURGICAL TECHNIQUE WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. IN CONCLUSION, NO CAUSE RELATED TO A COMPONENT OF THE IMPLANT SYSTEM FOR COULD BE FOUND WITH THE CURRENT DATA AT HAND. THE INCIDENT WAS ASSIGNED TO THE HAZARD "INCOMPATIBILITY" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANT CAST GMBH: "WHILE PLACING THE INSERT IT APPEARED THERE WAS A DEFECT AND WON'T DIDN'T FIT ON THE TIBIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144153 ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 2/10MM No Match JWH IMPLANTCAST GMBH 42454210

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 2/10MM| ACS® LD EXTENSION STEM MALE TAPER 14/25MM| ACS® LD FB+ TIBIA CEMENTED SZ. 2 RIGHT INCL. PLUGS| ACS® LD PS FEMORAL COMPONENT CEMENTED SZ. 3 RIGHT