BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20795724 · Received November 27, 2024

    Report

    Report Number
    3012523063-2024-00057
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 21, 2024
    Report Date
    November 27, 2024
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    JWH
    PMA / PMN Number
    K234044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPLANT CAST GMBH RECEIVED A REPORT, IN WHICH AN ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 5/10MM WAS NOT SUCCESSFULLY CONNECTED WITH THE CORRESPONDING TIBIAL PLATEAU DURING THE IMPLANTATION PROCESS. THE PE INSERT IN QUESTION WAS MADE AVAILABLE FOR AN OPTICAL INSPECTION. THIS PE INSERT SHOWS A LARGE NUMBER OF SMALL GROOVES ON THE TOP AND THE FRONT OF THE ANTERIOR REGION, WHICH WERE VERY LIKELY CAUSED BY REPEATED IMPACTION ATTEMPTS WITH THE IMPACTION INSTRUMENT FROM DIFFERENT ANGLES. IT WAS ALSO FOUND THAT THE SNAP-IN EDGE IS BENT UP. THE LINE OF THIS DEFORMATION IS AT AN ANGLE TO THE ORIGINAL SHAPE, WHICH INDICATES THAT THIS PE INSERT WAS NO POSITIONED CORRECTLY IN THE TIBIAL PLATEAU PRIOR TO THE IMPACTION. FURTHERMORE, THE SNAP-IN EDGE OF THE PE INSERT NOW HAS THE SHAPE OF A BEAK IN THE SIDE VIEW. IN THE PAST, A SERIES OF TRIALS WAS PERFORMED TO REPRODUCE THIS KIND OF DEFORMATION. IN THIS COURSE, IT WAS FOUND THAT THE FORMATION OF A BEAK SHAPE CAN ONLY BE REPRODUCED WITH INCORRECT POSITIONING OF THE PE INSERT. 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. BASED ON THE AVAILABLE DATA, IT WAS THEREFORE CONCLUDED THAT THE POSSIBLE CAUSE WAS NOT A FAULTY PRODUCT, BUT AN ERROR IN THE APPLICATION. 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 IMPLANT CAST GMBH: "DUE TO A DEFECT IN THE ACS PE INSERT, IT COULD NOT PROPERLY CONNECT WITH THE TIBIA. THE POSTERIOR PORTION WAS INSERTED SMOOTHLY; HOWEVER, THE ANTERIOR PART FAILED TO LOCK SECURELY. CONSEQUENTLY, A NEW PE INSERT WAS OPENED AND USED BY THE ATTENDING STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451812 ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 5/10MM No Match JWH IMPLANTCAST GMBH 42454510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ACS® FB+ TIBIA CEMENTED SZ. 5 LEFT INCL. PLUGS