BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 2/12.5 MM

    MDR report key: 21812356 · Received April 10, 2025

    Report

    Report Number
    3012523063-2025-00034
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 28, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    JWH
    PMA / PMN Number
    K234044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE IMPLANTCAST GMBH THAT AN ACS® FB+ PS PE INSERT HYPERFLEX SZ. 2/12.5 MM HAD TO BE REVISED AFTER AN IMPLANTATION PERIOD OF ABOUT 1 MONTH BECAUSE IT HAD DETACHED FROM THE TIBIAL COMPONENT. OPTICAL EXAMINATION OF THE EXPLANT WAS NOT POSSIBLE, AS IT WAS NOT PROVIDED TO THE IMPLANTCAST GMBH. THE MANUFACTURING DOCUMENTS, INSTRUCTIONS FOR USE AND DESCRIPTION OF THE SURGICAL TECHNIQUE WERE CHECKED, NO DEVIATIONS WERE FOUND. AS THE INCIDENT OCCURRED ALREADY AFTER A VERY SHORT PERIOD OF IMPLANTATION IN A PATIENT WITH A LOW ACTIVITY LEVEL, IT IS LIKELY THAT THE AFFECTED PE-INSERT WAS NOT PLACED CORRECTLY DURING THE IMPLANTATION SURGERY. HOWEVER, NO INFORMATION IS AVAILABLE TO CONFIRM THIS HYPOTHESIS. IN CONCLUSION, THE AVAILABLE DATA ARE NOT SUFFICIENT TO IDENTIFY THE ROOT CAUSE OF THE INCIDENT. THE INCIDENT WAS ASSIGNED TO THE HAZARD "TECHNICAL FAILURE" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE IMPLANTCAST GMBH THAT AN ACS® FB+ PS PE INSERT HYPERFLEX SZ. 2/12.5 MM HAD TO BE REVISED AFTER AN IMPLANTATION PERIOD OF ABOUT 1 MONTH BECAUSE IT HAD DETACHED FROM THE TIBIAL COMPONENT. THE OPTICAL EXAMINATION OF THE PE INSERT IN QUESTION REVEALED STRONG DEFORMATIONS AND INWARD BENDING OF THE POSTERIOR, MEDIAL AND LATERAL EDGES, INDICATING THAT THE PE INSERT HAS NOT BEEN INSERTED CORRECTLY/ COMPLETELY INTO THE LOCKING MECHANISM (DOVETAIL) OF THE TIBIAL COMPONENT BEFORE IMPACTION AS IT IS STATED IN THE CORRESPONDING SURGICAL TECHNIQUE. ON THE INFERIOR SURFACE OF THE PE SLIGHT INDENTATIONS ARE PRESENT. THIS SUGGEST THAT THE POSTERIOR EDGES OF THE PE-INSERT WERE STILL (PARTIALLY) ON TOP OF THE POSTERIOR GROOVE OF THE TIBIAL COMPONENT AND EXPERIENCED FORCE EFFECTS DURING WEIGHT BEARING ON THE JOINT, RESULTING IN THESE INDENTATIONS FROM CONTACT WITH THE TIBIAL COMPONENT. A SMALL NOTCH IS PRESENT ON THE SUPERIOR SIDE OF THE PE. THIS NOTCH PROBABLY RESULTS FROM IMPACTION WITH THE PE IMPACTOR. IT IS POSSIBLE THAT THE MALPOSITION OF THE PE INSERT RESULTED IN THE SLIGHT DEFORMATION OF THE ANTERIOR SNAP-IN EDGE DURING THIS PROCESS. CONSEQUENTLY, THE PE INSERT WAS NOT WELL FIXED AND ONLY REMAINED IN PLACE FOR A MONTH DUE TO THE LOW ACTIVITY LEVEL OF THE PATIENT. THE SMALL GROOVES ON THE SUPERIOR SIDE OF THE PE INSERT ARE PROBABLY A RESULT OF WEAR. THE MANUFACTURING DOCUMENTS, INSTRUCTIONS FOR USE AND DESCRIPTION OF THE SURGICAL TECHNIQUE WERE CHECKED, NO DEVIATIONS WERE FOUND. IN CONCLUSION, THE AVAILABLE DATA INDICATE THAT THE INCIDENT WAS NOT CAUSED BY A DEFECTIVE PRODUCT, BUT BY INAPPROPRIATE APPLICATION BY THE SURGEON. THE INCIDENT WAS ASSIGNED TO THE HAZARD "TECHNICAL FAILURE" IN THE ASSOCIATED RISK MANAGEMENT. THE FREQUENCY OF OCCURRENCE IS BELOW THE ACCEPTED LIMIT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "PE-INSERT DETACHED FROM THE TIBIAL COMPONENT. A TECHNICAL REVIEW OF THE TIBIAL COMPONENT AND PE-INSERT IS REQUIRED. PLEASE PROVIDE AN INVESTIGATION REPORT. THE REMOVED PRIMARY PE-INSERT (AFFECTED PRODUCT) IS BEING RETRIEVED AND WILL BE SENT BACK TO THE IMPLANTCAST."

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "PE-INSERT DETACHED FROM THE TIBIAL COMPONENT. A TECHNICAL REVIEW OF THE TIBIAL COMPONENT AND PE-INSERT IS REQUIRED. PLEASE PROVIDE AN INVESTIGATION REPORT. THE REMOVED PRIMARY PE-INSERT(AFFECTED PRODUCT) IS BEING RETRIEVED AND WILL BE SENT BACK TO THE IMPLANTCAST." FOLLOW-UP: IMPLANTCAST GMBH WAS PROVIDED WITH THE AFFECTED PRODUCT ON 04/01/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415400 ACS® FB+ PS PE-INSERT HYPERFLEX SZ. 2/12.5 MM PE-INSERT JWH IMPLANTCAST GMBH 42454212

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention ACS® FB TIBIAL SPACER MEDIAL SZ. 2 / 5 MM REF| ACS® FB TIBIAL SPACER MEDIAL SZ. 2 / 5 MM REF| ACS® FB+ TIBIA CEMENTED SZ. 2 RIGHT INCL. PLUGS| ACS® FB+ TIBIA CEMENTED SZ. 2 RIGHT INCL. PLUGS| ACS® LD EXTENSION STEM MALE TAPER 14 / 25 MM| ACS® LD EXTENSION STEM MALE TAPER 14 / 25 MM| ACS® PE-PATELLA CEMENTED 26 MM REF (B)(4)| ACS® PE-PATELLA CEMENTED 26 MM REF (B)(4)| ACS® PS FEMORAL COMPONENT CEMENTED SZ. 2.5 RIGHT| ACS® PS FEMORAL COMPONENT CEMENTED SZ. 2.5 RIGHT