BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 23858474 · Received December 20, 2025

    Report

    Report Number
    3005180920-2025-01288
    Event Type
    Injury
    Date Received
    December 20, 2025
    Date of Event
    December 8, 2025
    Report Date
    January 20, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: THE PRESENCE OF METALLOSIS AND THE PROVIDED DESCRIPTION SUGGEST RELATIVE MOVEMENT BETWEEN THE GLENOSPHERE AND THE BASEPLATE, IN ADDITION TO THE DESCRIBED BASEPLATE MOBILIZATION. THE X-RAY SHOWS RADIOLUCENT LINES BEHIND THE BASEPLATE BACKSURFACE AND AROUND THE CENTRAL POST, WHICH IS IN LINE WITH THE DESCRIBED BASEPLATE MOBILIZATION. THE PROVIDED PICTURES DO NOT SHOW ANY PARTICULAR UNEXPECTED SIGN. GIVEN THE INFORMATION AT HAND, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. NO ACTION IS SUGGESTED. ADDITIONAL INFORMATION: - H11 INVESTIGATION PERFORMED BY R&D PROJECT MANAGER.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 DEC 2025. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2403496: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2024. EXPIRATION DATE: 2029-JUN-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0302 GRS BASEPLATE - D 24.5X20 +6MM (K213459) LOT. 2308499: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2023. EXPIRATION DATE: 2028-NOV-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0170 GLENOSPHERE - D 39X24.5 (K170452) LOT. 2401263: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2024. EXPIRATION DATE: 2029-MAY-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER D 39/+3MM (K170452) LOT. 2402706: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2024. EXPIRATION DATE: 2029-MAY-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT. REVISION SURGERY WAS PERFORMED 1 YEAR AND 2 MONTHS AFTER THE PREVIOUS PROCEDURE DUE TO INSTABILITY. THIS WAS THE PATIENT’S SECOND REVISION, ALTHOUGH THE INITIAL IMPLANTS WERE NOT FROM MEDACTA. DURING THE REVISION, THE GLENOSPHERE SCREW AND THE BASEPLATE WERE FOUND TO BE LOOSE, AND ABUNDANT METALLOSIS DEBRIS WAS OBSERVED AT THE GLENOSPHERE/BASEPLATE INTERFACE. AS THE EXPLANTED COMPONENTS HAVE NOT BEEN EXAMINED YET, IT IS NOT POSSIBLE TO DETERMINE THE EXACT ORIGIN OF THESE FINDINGS; HOWEVER, THEY MAY BE RELATED TO INSUFFICIENT TIGHTENING OF THE SCREW, ALTHOUGH THE UNDERLYING CAUSE LEADING TO THIS CONDITION CANNOT BE DEFINITIVELY IDENTIFIED. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY RIGHT SHOULDER SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2024, THE PATIENT WAS REVISED WITH MEDACTA PRODUCTS. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO INSTABILITY. THE SURGEON FOUND ~40-50CC OF GRAY FLUID CONSISTENT WITH METALLOSIS. THE GLENOSPHERE SCREW WAS FOUND TO BE LOOSE, AND ABUNDANT METALLOSIS DEBRIS AT THE GLENOSPHERE/BASEPLATE INTERFACE. THE BASEPLATE WAS FOUND TO BE LOOSE IN THE GLENOID, AND DUE TO THE CAVITY LEFT BEHIND FROM THE BASEPLATE POST, THE CAVITY WAS FILLED WITH CANCELLOUS BONE CHIPS AND DBM PUTTY. THE SURGEON CONVERTED THE PATIENT TO A HEMIARTHROPLASTY WITH PLANS FOR THE PATIENT TO RETURN FOR A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591700 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2403496 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention