BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILON® METAPHYSEAL COMPONENT OMARTHROSIS INCL. SAFETY SCREW

    MDR report key: 24078149 · Received January 15, 2026

    Report

    Report Number
    3012523063-2026-00001
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    August 25, 2025
    Report Date
    January 15, 2026
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HSD
    PMA / PMN Number
    K191433
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO IMPLANTCAST GMBH THAT THE PATIENT HAD TO BE REVISED APPROXIMATELY 27 MONTHS AFTER IMPLANTATION DUE TO A CHRONICALLY FISTULATING INFECTION. THE EXPLANTED PRODUCTS WERE NOT RETURNED TO IMPLANTCAST GMBH. THEREFORE, OPTICAL EXAMINATION WAS NOT POSSIBLE. X-RAYS INCLUDED IN THE AVAILABLE HOSPITAL DISCHARGE LETTER ONLY DISPLAY THE SITUATION AFTER EXPLANTATION OF THE PROSTHESIS. ACCORDING TO THE DISCHARGE LETTER, THE PATIENT RECEIVED TREATMENT BY IRRIGATION AND DRAINAGE OF AN AXILLARY ABSCESS WERE PERFORMED ON (B)(6) 2025, PRIOR TO THE EXPLANTATION THAT TOOK PLACE ON (B)(6) 2025. MATERIAL CERTIFICATES AND MANUFACTURING DOCUMENTS WERE CHECKED AND DID NOT DISPLAY ANY ERRORS. SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AS WELL AND DID NOT SHOW ANY DEVIATIONS. ADDITIONALLY, STERILIZATION CERTIFICATES OF THE MAIN COMPONENT AND ALL COMBINATION PRODUCTS WERE CHECKED AS WELL AND DID NOT SHOW ANY DEVIATIONS. NO FAILURE DURING THE MANUFACTURING PROCESS COULD BE DETERMINED WHICH MIGHT HAVE CAUSED THE INFECTION. BASED ON ALL AVAILABLE INFORMATION, IT IS CONCLUDED THAT THE PRODUCTS IN QUESTION WERE NOT CAUSAL FOR THE DESCRIBED INFECTION. THE EVENT WAS ASSIGNED TO THE ERROR PATTERNS "INFECTION" AND "PERI-PROSTHETIC FRACTURE" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "CHRONIC FISTULATING PERIPROSTHETIC INFECTION OF THE REVERSE SHOULDER PROSTHESIS ON THE RIGHT, ABSCESS IN THE RIGHT AXILLA, PROXIMAL HUMERAL OSTEITIS ON THE RIGHT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145783 AGILON® METAPHYSEAL COMPONENT OMARTHROSIS INCL. SAFETY SCREW PROSTHESIS HSD IMPLANTCAST GMBH 38210002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other AGILON® CAP 47/17 MM| AGILON® GLENOID CEMENTLESS ANATOMICAL SZ. 3 SHORT| AGILON® GLENOID PE-INSERT SZ. 3| AGILON® SCREW M6/22,5MM| AGILON® STEM CEMENTLESS Ø13/60MM| CANCELLOUS SCREW ANGLE STABLE Ø 4,2 X 26MM| CANCELLOUS SCREW ANGLE STABLE Ø 4,2 X 28MM