BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILON® XO SCREW M6/22.5MM

    MDR report key: 23288224 · Received October 15, 2025

    Report

    Report Number
    3012133896-2025-00003
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 23, 2024
    Report Date
    October 14, 2024
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN AGILON® XO SCREW WAS FOUND TO BE BROKEN APPROX. 15 MONTHS AFTER THE IMPLANTATION. ADDITIONALLY, ON THE PROVIDED X-RAY IMAGES CAN BE SEEN THAT THE SAFETY SCREW BECAME LOOSE. THE AFFECTED PRODUCTS WERE NOT SENT TO IMPLANT CAST GMBH FOR THE INVESTIGATIONS, AS THE REVISION HAS NOT TAKEN PLACE YET. THE PROVIDED X-RAYS SHOW THAT THE SCREW BROKE AT THE THREAD IN A WAY, THAT THE LOWER PART OF THE THREAD IS STILL POSITIONED IN THE HUMERUS STEM. FURTHERMORE, IT IS NOTICEABLE THAT THE SAFETY SCREW BECAME LOOSE AND IS NOT IN ITS ORIGINAL POSITION ANYMORE. THE MANUFACTURING DOCUMENTS AND THE INSTRUCTIONS FOR USE WERE CHECKED AND BOTH REVEALED NO ERRORS IN TERMS OF CONTENT. HOWEVER, THE SURGICAL TECHNIQUE CLEARLY STATES THE USE OF A TORQUE WRENCH TO TIGHTEN THE SAFETY SCREW, WHICH HAS THE TASK TO SECURE THE AGILON® XO SCREW FROM LOOSENING. THE SURGEON INDICATED THAT THE TORQUE WRENCH WAS USED, BUT THAT THE HUMERUS WAS DIFFICULT TO GRASP FOR TIGHTENING. BASED ON THE INFORMATION AVAILABLE, NO TECHNICAL CAUSE COULD BE IDENTIFIED THAT IS ATTRIBUTABLE TO A DEFECTIVE PRODUCT. THE X-RAYS INDICATE THAT THE METAPHYSEAL COMPONENT WAS NOT CORRECTLY IMPLANTED SINCE THE SHIELD OF THIS COMPONENT IS NOT POSITIONED CORRECTLY ON THE HUMERUS AND A GAP IS VISIBLE AT THIS SITE. A MEDICAL EXPERT ASSESSMENT DETERMINED THAT THE 'FLAGPOLE FIXATION' PHENOMENON WAS PRESENT DUE TO POOR INTEGRATION AND ASEPTIC LOOSENING OF THE PROXIMAL METAPHYSEAL COMPONENT, RESULTING IN INADEQUATE FIXATION AND A LACK OF BONE INGROWTH. IN CONTRAST, THE DISTAL REGION REMAINED STABLE. THIS DISPARITY IN FIXATION QUALITY LED TO AN UNFAVOURABLE DISTRIBUTION OF FORCES, CAUSING STRESS SHIELDING THAT FURTHER COMPROMISED DISTAL FIXATION. IT IS ALSO KNOWN THAT THE SURGEON HAD USED A TORQUE WRENCH TO TIGHTEN THE SAFETY SCREW, FOR THAT THIS STEP IS CRUCIAL AND DESCRIBED IN THE SURGICAL TECHNIQUE. HOWEVER, THE SURGEON DESCRIBED THIS STEP AS DIFFICULT, FOR THAT REASON THE SAFETY SCREW WAS PROBABLY NOT TIGHTENED PROPERLY. IT IS SUSPECTED THAT THE SCREWS WERE INSUFFICIENTLY TIGHTENED. THIS HYPOTHESIS IS SUPPORTED BY THE FACT THAT IT WAS REPORTED THAT THE SURGEON DID NOT USE THE PRESCRIBED TORQUE WRENCH OPTIMALLY. IN ADDITION, THE X-RAYS SHOW THAT THE METAPHYSEAL COMPONENT HAS LOOSENED ASEPTICALLY OVER TIME. WITH CONTINUED FIRM DISTAL ANCHORING, THIS LEADS TO THE PROSTHESIS BEING ABLE TO SWING. BOTH ASPECTS LEAD TO AN INSTABILITY OF THE OVERALL SYSTEM RESULTING IN A LOOSENING OF THE SCREWS AND ULTIMATELY TO A FATIGUE FRACTURE OF THE SCREW. HOWEVER DUE TO LACK OF INFORMATION, THIS CAN NEITHER BE CONFIRMED OR DENIED. THE PRESENT EVENTS WERE ASSIGNED TO THE ERROR PATTERNS "IMPLANT FAILURE", "TECHNICAL FAILURE / LOOSENING OF MODULAR CONNECTIONS / LOOSENING OF FIXATION OF THE ATTACHMENT TUBE" AND "ASEPTIC LOOSENING" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    AN AGILON® XO SCREW WAS FOUND TO BE BROKEN APPROX. 15 MONTHS AFTER THE IMPLANTATION. ADDITIONALLY, ON THE PROVIDED X-RAY IMAGES CAN BE SEEN THAT THE SAFETY SCREW BECAME LOOSE. THE AFFECTED PRODUCTS WERE NOT SENT TO IMPLANTCAST GMBH FOR THE INVESTIGATIONS. ALSO, THE EXPLICIT REF NUMBERS OF ANY OF THE IMPLANTED PRODUCTS WERE NOT PROVIDED FOR THE INVESTIGATIONS. HOWEVER, FROM THE PROVIDED X-RAY IMAGES IT WAS POSSIBLE TO TRACE DOWN THE AFFECTED AGILON® XO SCREW IN THIS WAY. THE OTHER PRODUCTS WERE DETERMINED BASED ON THE AVAILABLE X-RAY IMAGES AND THE SURGERY TECHNIQUE. THE PROVIDED X-RAYS SHOW THAT THE SCREW BROKE AT THE THREAD IN A WAY, THAT THE LOWER PART OF THE THREAD IS STILL POSITIONED IN THE HUMERUS STEM. FURTHERMORE, IT IS NOTICEABLE THAT THE COUNTER SCREW BECAME LOOSE AND IS NOT IN ITS ORIGINAL POSITION ANYMORE. IT WAS NOT POSSIBLE TO CHECK THE MANUFACTURING DOCUMENTS, SINCE THE LOT NUMBERS OF THE AFFECTED PRODUCTS WERE NOT AVAILABLE. A REVIEW OF THE INSTRUCTIONS FOR USE REVEALED NO ERRORS IN TERMS OF CONTENT. HOWEVER, THE SURGICAL TECHNIQUE CLEARLY STATES THE USE OF A TORQUE WRENCH TO TIGHTEN THE COUNTER SCREW, WHICH HAS THE TASK TO SECURE THE AGILON® XO SCREW FROM LOOSENING. THERE IS NO SECURED INFORMATION WHETHER THE TORQUE WRENCH WAS USED FOR THIS PURPOSE DURING THE IMPLANTATION OR NOT BASED ON THE INFORMATION AVAILABLE, NO TECHNICAL CAUSE COULD BE IDENTIFIED THAT IS ATTRIBUTABLE TO A DEFECTIVE PRODUCT. THE X-RAYS INDICATE THAT THE METAPHYSEAL COMPONENT WAS NOT CORRECTLY IMPLANTED SINCE THE SHIELD OF THIS COMPONENT IS NOT POSITIONED CORRECTLY ON THE HUMERUS AND A GAP IS VISIBLE AT THIS SITE. IT IS ALSO NOT KNOWN, IF THE SURGEON HAD USED A TORQUE WRENCH TO TIGHTEN THE COUNTER SCREW, FOR THAT THIS STEP IS CRUCIAL AND DESCRIBED IN THE SURGICAL TECHNIQUE. IT IS ASSUMED THAT THE COMBINATION OF THE WRONGLY POSITIONED METAPHYSEAL COMPONENT AND REGULAR MOVEMENTS AND STRESSES ON THE JOINT COULD HAVE LED TO A LOOSENING OF THE COUNTER SCREW, WHICH RESULTED IN AN INCREASING RANGE OF MOTION AND ENDED WITH A FRACTURED AGILON® XO SCREW. HOWEVER, DUE TO LACK OF INFORMATION, THIS CAN NEITHER BE CONFIRMED OR DENIED. THE PRESENT EVENTS WERE ASSIGNED TO THE ERROR PATTERNS "IMPLANT FAILURE" AND "TECHNICAL FAILURE / LOOSENING OF MODULARCONNECTIONS / LOOSENING OF FIXATION OF THE ATTACHMENT TUBE" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANT CAST GMBH ON (B)(6) 2024: "SCREW HAS BACKED OUT OF COMPONENT." ADDITIONALLY, THE SURGEON INDICATES THE SCREW BETWEEN THE STEM AND THE METAPHYSEAL COMPONENT TO BE TOO SHORT. FURTHERMORE, THE PROVIDED X-RAY IMAGES CLEARLY SHOW A FRACTURE OF THE AGILON® XO SCREW. BASED ON THE AVAILABLE INFORMATION, THE INCIDENT WILL BE SPLIT AND THE FOLLOWING ERROR PATTERNS WILL BE CONSIDERED: · 20230924A_1: FRACTURE OF THE AGILON® XO SCREW · 20240924A_2: LOOSENING OF THE SAFETY SCREW · 20240924A_3: ASEPTIC LOOSENING OF THE AGILON® METAPHYSEAL COMPONENT THE FOLLOWING FOLLOW-UP INFORMATION WERE RECEIVED BY IMPLANT CAST GMBH: · DETAILED INFORMATION ON THE AFFECTED PRODUCTS AND THE USE OF A TORQUE WRENCH DURING IMPLANTATION; THE SURGEON REPORTED THAT WHILE THE TORQUE WRENCH WAS USED, THE HUMERUS WAS DIFFICULT TO GRIP FOR TIGHTENING, ON (B)(6) 2024. · MEDICAL ASSESSMENT AND INDICATION OF ASEPTIC LOOSENING OF THE METAPHYSEAL COMPONENT, ON (B)(6) 2024.

    Description of Event or Problem · 0

    THE IMPLANTCAST GMBH RECEIVED X-RAY IMAGES THAT CLEARLY SHOW A FRACTURED AGILON® XO SCREW AND A LOOSENED COUNTER SCREW. FURTHER DESCRIPTIONS OF THE EVENT WERE NOT MADE AVAILABLE. BASED ON THE AVAILABLE INFORMATION, THE INCIDENT WILL BE SPLIT AND THE FOLLOWING ERROR PATTERNS WILL BE CONSIDERED: - (B)(6) (3012523063-2024-00043): FRACTURE OF THE AGILON® XO SCREW. - (B)(6) (3012523063-2024-00051): LOOSENING OF THE SAFETY SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187667 AGILON® XO SCREW M6/22.5MM PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD IMPLANTCAST GMBH 38610022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention AGILON® METAPHYSEAL COMPONENT OMARTHROSIS REF (B)(4).| AGILON® STEM CEMENTLESS REF.| AGILON® XO CAP REF (B)(4).| AGILON® XO GLENOID CEMENTLESS CPTI.| AGILON® XO GLENOSPHERE REF (B)(4).| AGILON® XO INVERSE CAP BASE REF(B)(4).| SAFETY SCREW M10/1 SW5 REF (B)(4).