BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS® FB+ SC PE-INSERT SZ. 3/10MM

    MDR report key: 21948072 · Received May 2, 2025

    Report

    Report Number
    3012523063-2025-00049
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    April 4, 2025
    Report Date
    September 2, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    JWH
    PMA / PMN Number
    K234044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FEMALE PATIENT WAS TREATED WITH AN ACS® FB+ PROSTHESIS. IT WAS REPORTED THAT THE ACS® FB+ SC PE-INSERT EJECTED TWICE INTRAOPERATIVELY AFTER CONNECTING IT TO THE TIBIAL COMPONENT AND BENDING THE KNEE JOINT ACCORDING TO THE SURGICAL TECHNIQUE. IT IS KNOWN THAT THE EJECTION OF THE PE-INSERT CAUSED AN EXTENSION OF THE OPERATION TIME OF APPROX. 20 MINUTES. ULTIMATELY, A DIFFERENT PE-INSERT WAS IMPLANTED AS PLANNED. THE AFFECTED IMPLANTS WERE NOT SENT TO IMPLANTCAST GMBH FOR THE OPTICAL EXAMINATION. SINCE NO PICTURE OF THE PRODUCT WAS PROVIDED NEITHER, NO OPTICAL EXAMINATION COULD BE PERFORMED. THE MANUFACTURING DOCUMENTS OF THE PE-INSERT AND THE INSTRUCTIONS FOR USE WERE CHECKED AND BOTH REVEALED NO ERRORS IN TERMS OF CONTENT. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. BASED ON THE AVAILABLE INFORMATION IT COULD NOT BE DETERMINED WHY THE REPORTED ERROR PATTERN OCCURRED. HOWEVER, IT IS ALSO POSSIBLE, THAT THE PE-INSERT WAS INITIALLY CONNECTED WRONGLY TO THE TIBIAL COMPONENT, WHICH COULD HAVE RESULTED IN A DEFORMATION OF THE FLAPS AND THUS WOULD NOT CONNECT TO THE TIBIAL PART ANYMORE. HOWEVER, THIS CAN NEITHER BE CONFIRMED NOR DENIED DUE TO LACK OF INFORMATION. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERN "INCOMPATIBILITY" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    A FEMALE PATIENT WAS TREATED WITH AN ACS® FB+ PROSTHESIS. IT WAS REPORTED THAT THE ACS® FB+ SC PE-INSERT EJECTED TWICE INTRAOPERATIVELY AFTER CONNECTING IT TO THE TIBIAL COMPONENT AND BENDING THE KNEE JOINT ACCORDING TO THE SURGICAL TECHNIQUE. IT IS KNOWN THAT THE EJECTION OF THE PE-INSERT CAUSED AN EXTENSION OF THE OPERATION TIME OF APPROX. 20 MINUTES. ULTIMATELY, A DIFFERENT PE-INSERT WAS IMPLANTED AS PLANNED. THE AFFECTED IMPLANT WAS SENT TO IMPLANTCAST GMBH FOR THE OPTICAL EXAMINATION. THE DEFORMATION OF THE SNAP-IN EDGES AT THE BOTTOM OF THE PE INSERT SUGGEST THAT IT WAS NOT INSERTED CORRECTLY FROM ANTERIOR INTO THE TIBIAL COMPONENT BEFORE IMPACTION, AS IT IS STATED IN THE CORRESPONDING SURGICAL TECHNIQUE. THUS, A HANDLING ERROR HAS PROBABLY OCCURRED WHILE CONNECTING THE PE-INSERT WITH THE TIBIAL COMPONENT. THE MANUFACTURING DOCUMENTS OF THE PE-INSERT WERE CHECKED, AND BOTH REVEALED NO ERRORS IN TERMS OF CONTENT. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. BASED ON THE AVAILABLE INFORMATION IT IS POSSIBLE, THAT THE PE-INSERT WAS INITIALLY CONNECTED WRONGLY TO THE TIBIAL COMPONENT. THIS COULD HAVE RESULTED IN A DEFORMATION OF THE SNAP-IN EDGES AND THUS IT IS NO LONGER POSSIBLE TO ENGAGE THE PE INSERT IN THE DOVETAIL OF THE TIBIAL COMPONENT. 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 INLAY WAS INSERTED (WE WERE ALL SURE THAT IT WAS IN CORRECTLY), THE INLAY POPPED OUT ANTERIORLY WHEN THE KNEE JOINT WAS BENT! AFTER VISUAL INSPECTION OF THE "FLAPS", WHICH SHOWED NO DAMAGE, THE INLAY WAS REINSERTED. WHEN FLEXING AGAIN, AS SOON AS PRESSURE WAS APPLIED TO THE POSTERIOR INLAY VIA THE CONDYLES, IT POPPED OUT AGAIN ANTERIORLY!"

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "AFTER THE INLAY WAS INSERTED (WE WERE ALL SURE THAT IT WAS IN CORRECTLY), THE INLAY POPPED OUT ANTERIORLY WHEN THE KNEE JOINT WAS BENT! AFTER VISUAL INSPECTION OF THE "FLAPS", WHICH SHOWED NO DAMAGE, THE INLAY WAS REINSERTED. WHEN FLEXING AGAIN, AS SOON AS PRESSURE WAS APPLIED TO THE POSTERIOR INLAY VIA THE CONDYLES, IT POPPED OUT AGAIN ANTERIORLY!" THIS FOLLOW-UP REPORT HAS BEEN CREATED SINCE THE AFFECTED IMPLANT BECAME AVAILABLE FOR OPTICAL INVESTIGATION ON 4TH OF AUGUST 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209001 ACS® FB+ SC PE-INSERT SZ. 3/10MM ACS® FB+ SC PE-INSERT SZ. 3/10MM JWH IMPLANTCAST GMBH 42455310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention ACS® FB+ TIBIA CEMENTED SZ. 3 LEFT INCL. PLUGS| ACS® FB+ TIBIA CEMENTED SZ. 3 LEFT INCL. PLUGS