BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILON® XO INVERSE CAP BASE 40 MM S

    MDR report key: 23301076 · Received October 15, 2025

    Report

    Report Number
    3012133896-2025-00016
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    March 17, 2025
    Report Date
    November 15, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE IMPLANTCAST GMBH THAT AN AGILON XO INVERSE CAP BASE Ø40 MM S BROKE AFTER 3 YEARS 10 MONTHS OF IMPLANTATION. NEITHER THE EXPLANTS NOR INTRAOPERATIVE IMAGES WERE AVAILABLE FOR AN OPTICAL EXAMINATION. X-RAY IMAGES WERE AVAILABLE THAT HAD BEEN TAKEN BEFORE AND AFTER THE INCIDENT. THE X-RAY TAKEN PRIOR TO THE INCIDENT REVEALS A GAP BETWEEN THE METAPHYSEAL COMPONENT PLATE AND THE BONE SURFACE. THIS INDICATES INSUFFICIENT BONE SUPPORT, WHICH ALLOWS MICRO-MOVEMENTS TO OCCUR UNDER LOAD. FURTHERMORE, THERE IS A SLIGHT ANGULAR DEVIATION BETWEEN THE STEM AND THE METAPHYSEAL COMPONENT. THIS SUGGESTS THAT THE SCREW WAS NOT FULLY TIGHTENED, RESULTING IN A UNSUFFICIENT CONNECTION BETWEEN THE TWO COMPONENTS. AFTER THE FRACTURE, HOWEVER, THE ANGULAR DEVIATION IS NO LONGER VISIBLE. AS THERE IS NO LONGER ANY STRESS ON THE METAPHYSEAL COMPONENT DUE TO THE FRACTURE, IT HAS RETURNED TO ITS NORMAL STATE. ADDITIONALLY, A FLAGPOLE SITUATION WAS OBSERVED. DISTALLY, THE SYSTEM IS WELL ANCHORED BY THE STEM. PROXIMALLY, LYSIS LINES INDICATE POSSIBLE LOOSENING. THIS ALLOWS FOR OSCILLATION, AMPLIFYING POSSIBLE MICRO-MOVEMENTS AND INCREASING THE LIKELIHOOD OF AN OSCILLATION FRACTURE. THE MANUFACTURING DOCUMENTS, INSTRUCTIONS FOR USE AND DESCRIPTION OF THE SURGICAL TECHNIQUE WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. THE SURGICAL TECHNIQUE SPECIFIES THAT A TORQUE WRENCH MUST BE USED TO TIGHTEN THE CONNECTING SCREW. IT IS NOT KNOWN WHETHER A TORQUE WRENCH WAS USED DURING IMPLANTATION. IT IS KNOWN THAT THE PATIENT FELL PREVIOUS TO THE INCIDENT. IN CONCLUSION, NO SPECIFIC CAUSE OF THE FRACTURE COULD BE IDENTIFIED. HOWEVER, IT IS POSSIBLE THAT THE PATIENT'S PREVIOUS FALL, IN COMBINATION WITH THE LOOSE CONNECTION BETWEEN THE METAPHYSEAL COMPONENT AND THE STEM, AS WELL AS INSUFFICIENT BONE SUPPORT, CAUSED THE FRACTURE. THE INCIDENT WAS ASSIGNED TO THE HAZARD "IMPLANT FAILURE" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE IMPLANTCAST GMBH THAT AN AGILON® XO INVERSE CAP BASE 40 MM S BROKE AFTER 3 YEARS 10 MONTHS OF IMPLANTATION. NEITHER THE EXPLANTS NOR INTRAOPERATIVE IMAGES WERE AVAILABLE FOR AN OPTICAL EXAMINATION. THE MANUFACTURING DOCUMENTS, INSTRUCTIONS FOR USE AND DESCRIPTION OF THE SURGICAL TECHNIQUE WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. IT IS KNOWN THAT THE PATIENT FELL PREVIOUS TO THE INCIDENT. IN CONCLUSION, NO SPECIFIC CAUSE FOR THE FRACTURE COULD BE FOUND. HOWEVER, IT IS POSSIBLE THAT THE PATIENT'S PREVIOUS FALL WAS THE CAUSE. THE INCIDENT WAS ASSIGNED TO THE HAZARD "IMPLANT FAILURE" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "TRAUMA/FALL LED TO REVISION SURGERY; BROKEN TAPER ON THE BASE " FOLLOW-UP: IMPLANTCAST GMBH WAS PROVIDED WITH X-RAY IMAGES ON (B)(6) 2025. A MEDICAL REPORT HAS ALSO BEEN COMMISSIONED.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "TRAUMA/FALL LED TO REVISION SURGERY; BROKEN TAPER ON THE BASE "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289653 AGILON® XO INVERSE CAP BASE 40 MM S INVERSE CAP PHX IMPLANTCAST GMBH 38634000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention AGILON® METAPHYSEAL COMPONENT OMARTHROSIS 135°.| AGILON® STEM CEMENTLESS 16 / 60 MM.| AGILON® XO GLENOID CEMENTLESS CPTI 35 MM CPTI 35MM.| AGILON® XO GLENOSPHERE 40 MM NEUTRAL INCL. SCREW.| AGILON® XO INVERSE CAP BASE 40 MM S.| AGILON® XO PE-INSERT FOR INVERSE CAP 40 MM.| AGILON® XO SCREW M6 / 22.5 MM.| CANCELLOUS SCREW ANGLE STABLE 4.2 / 26 MM.| CANCELLOUS SCREW ANGLE STABLE 4.2 / 32 MM.| CANCELLOUS SCREW ANGLE STABLE 4.2 / 32 MM.| CANCELLOUS SCREW ANGLE STABLE 4.2 / 40 MM.