BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFETY SCREW M10/1 SW5

    MDR report key: 23297489 · Received October 15, 2025

    Report

    Report Number
    3012133896-2025-00011
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    December 13, 2024
    Report Date
    October 13, 2025
    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 AND A SAFETY SCREW WERE FOUND TO BE LOOSENED APPROX. 12 MONTHS AFTER THE IMPLANTATION. ADDITIONALLY, THE PROVIDED X-RAY IMAGES SHOW THE LOOSENED METAPHYSEAL COMPONENT, A DEFORMED CANCELLOUS SCREW AND A FRACTURED CANCELLOUS SCREW. THE AFFECTED PRODUCTS WERE NOT SENT TO IMPLANTCAST GMBH FOR INVESTIGATIONS. THE PROVIDED X-RAYS SHOW THAT THE COMBINED PRODUCTS BECAME LOOSE AND WERE NOT IN THEIR ORIGINAL POSITION ANYMORE. ONE OF THE CANCELLOUS SCREWS IS BENT WHILE THE OTHER ONE IS FRACTURED AT THE TIP. 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 THAT A TORQUE WRENCH MUST BE USED TO TIGHTEN THE SAFETY SCREW, WHICH HAS THE TASK TO SECURE THE AGILON® XO SCREW FROM LOOSENING. IT IS NOT CONFIRMED, IF THE TORQUE WRENCH WAS USED DURING THE IMPLANTATION OF THE PRODUCTS, HOWEVER IT WAS AVAILABLE DURING THE SURGERY. IT IS SUSPECTED THAT THE SCREWS WERE INSUFFICIENTLY TIGHTENED. 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 IN THE WORST CASE TO A FATIGUE FRACTURE OF THE SCREW. HOWEVER DUE TO LACK OF INFORMATION, THIS CAN NEITHER BE CONFIRMED NOR DENIED. THE DEFORMATION AND FRACTURE OF THE CANCELLOUS SCREWS COULD HAVE BEEN THE RESULT OF A WRONG POSITIONING OF THE SCREW IN COMBINATION WITH HIGH STRESSES WITHIN THE IMPLANTED SYSTEM. THE PRESENT EVENTS WERE ASSIGNED TO THE ERROR PATTERNS "TECHNICAL FAILURE / LOOSENING OF MODULARCONNECTIONS / LOOSENING OF FIXATION OF THE ATTACHMENT TUBE", "ASEPTIC LOOSENING" AND "IMPLANT FAILURE" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH ON 12/17/2024: "SAFETY SCREW AND AGILON XO SCREW HAVE BACKED OUT, PATIENT REVISED". ADDITIONALLY, IMPLANTCAST GMBH WAS INFORMED THAT THE SURGEON REMOVED THE METAPHYSEAL COMPONENT, SCREW, AND BASE/INSERT AND REPLACED IT. A TORQUE WRENCH WAS AVAILABLE DURING THE SURGERY. HOWEVER, IT IS NOT CONFIRMED WHETHER THE TORQUE WRENCH WAS USED DURING THE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289152 SAFETY SCREW M10/1 SW5 PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD IMPLANTCAST GMBH 38200101

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention AGILON® METAPHYSEAL COMPONENT OMARTHROSIS 135°| AGILON® STEM CEMENTLESS Ø15/60MM| AGILON® XO GLENOID CEMENTLESS CPTI 35 MM| AGILON® XO GLENOSPHERE Ø40MM NEUTRAL INCL. SCREW| AGILON® XO INVERSE CAP BASE Ø40MM S| AGILON® XO PE-INSERT FOR INVERSE CAP Ø40| AGILON® XO SCREW M6/22.5MM| CANCELLOUS SCREW ANGLE STABLE Ø4.2/20MM| CANCELLOUS SCREW ANGLE STABLE Ø4.2/32MM| CANCELLOUS SCREW Ø4.0/28MM| CANCELLOUS SCREW Ø4.0/28MM