BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 3/10MM

    MDR report key: 23093689 · Received September 19, 2025

    Report

    Report Number
    3012523063-2025-00083
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 18, 2025
    Report Date
    October 23, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    JWH
    PMA / PMN Number
    K234044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPLANTCAST GMBH RECEIVED A REPORT, IN WHICH AN ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 3/10MM WAS NOT SUCCESSFULLY CONNECTED WITH THE CORRESPONDING TIBIAL COMPONENT DURING THE IMPLANTATION PROCESS. PICTURES OF THE PE INSERT WERE MADE AVAILABLE FOR A LIMITED OPTICAL EXAMINATION. THE PE INSERT SHOWS A DAMAGE ON THE TOP WHICH WAS LIKELY CAUSED BY REPEATED IMPACTION ATTEMPTS WITH THE IMPACTION INSTRUMENT. IT WAS ALSO FOUND THAT THE SNAP-IN-EDGE MAY ALSO BE DAMAGED. THIS SUGGESTS THAT THE PE INSERT MAY NOT HAVE BEEN CORRECTLY POSITIONED. HOWEVER, TO DETERMINE THIS DEFINITIVELY, THE INLAY MUST BE ASSESSED. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE ACS® FB+ PS PE-INSERT WERE CHECKED. THESE DID NOT REVEAL ANY ERRORS. THE SURGICAL TECHNIQUE AND INSTRUCTIONS FOR USE WERE ALSO CHECKED AND SHOWED NO DEVIATIONS. IN CONCLUSION, THE AVAILABLE DATA ARE NOT SUFFICIENT TO IDENTIFY THE ROOT CAUSE OF THE INCIDENT. IT IS POSSIBLE THAT THE EVENT DESCRIBED WAS CAUSED BY INCORRECT APPLICATION. HOWEVER, THIS MUST BE CONFIRMED BY AN EXPLANT ASSESSMENT. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERN "INCOMPATIBILITY" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    THE IMPLANTCAST GMBH RECEIVED A REPORT, IN WHICH AN ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 3/10MM WAS NOT SUCCESSFULLY CONNECTED WITH THE CORRESPONDING TIBIAL COMPONENT DURING THE IMPLANTATION PROCESS. OPTICAL EXAMINATION OF THE PE INSERT IN QUESTION SUGGEST THAT IT WAS NOT INSERTED CORRECTLY FROM ANTERIOR INTO THE TIBIAL COMPONENT BEFORE IMPACTION, AS IT IS STATED IN THE CORRESPONDING SURGICAL TECHNIQUE. THE POINTED/BEAK-LIKE SHAPE OF THE SNAP-IN EDGE CORRESPONDS TO THE DEFORMATION ALSO OBSERVED IN INTERNAL STUDIES, WHICH OCCURS WHEN THE IMPACTOR IS PLACED VERTICALLY FROM ABOVE ON THE PE INSERT OR WHEN THE INSERT IS NOT FULLY INSERTED INTO THE TIBIA BEFORE IMPACTING. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE ACS® FB+ PS PE-INSERT WERE CHECKED. THESE DID NOT REVEAL ANY ERRORS. THE SURGICAL TECHNIQUE AND INSTRUCTIONS FOR USE WERE ALSO CHECKED AND SHOWED NO DEVIATIONS. IN CONCLUSION, THE AVAILABLE DATA INDICATE THAT THE INCIDENT WAS NOT CAUSED BY A DEFECTIVE PRODUCT, BUT BY INAPPROPRIATE APPLICATION BY THE SURGEON. THIS EVENT 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: "AFTER THE TRIAL, THE PE INSERT FAILED TO ENGAGE WITH THE TIBIA AT THE TIME OF REAL IMPLANT INSERTION. REPOSITIONING AND IMPACTING WERE ATTEMPTED, BUT ONLY HALFWAY THROUGH, FAILING TO ENGAGE. A DIFFERENT PE INSERT WAS TRIED, AND IT ENGAGED WITHOUT ISSUE, ENDING THE SURGERY. THE PRODUCT WAS RECALLED AND RE-ENGAGED BY ICA, BUT THE SAME FAILURE TO ENGAGE OCCURRED AS DURING THE SURGERY. ".

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "AFTER THE TRIAL, THE PE INSERT FAILED TO ENGAGE WITH THE TIBIA AT THE TIME OF REAL IMPLANT INSERTION. REPOSITIONING AND IMPACTING WERE ATTEMPTED, BUT ONLY HALFWAY THROUGH, FAILING TO ENGAGE. A DIFFERENT PE INSERT WAS TRIED, AND IT ENGAGED WITHOUT ISSUE, ENDING THE SURGERY. THE PRODUCT WAS RECALLED AND RE-ENGAGED BY ICA, BUT THE SAME FAILURE TO ENGAGE OCCURRED AS DURING THE SURGERY. " FOLLOW-UP: IMPLANTCAST GMBH WAS PROVIDED WITH THE AFFECTED PRODUCT ON 09/24/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269279 ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 3/10MM PE-INSERT JWH IMPLANTCAST GMBH 42454310

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention ACS® LD FB+ TIBIA CEMENTED SZ. 3,5 RIGHT