BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 24454893 · Received February 26, 2026

    Report

    Report Number
    3005180920-2026-00170
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    February 4, 2026
    Report Date
    February 26, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 FEB 2026. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2429766: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 FEB 2025. EXPIRATION DATE: 2030-FEB-11. 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 04.01.0119 HUMERAL REVERSE HC LINER D 36/+0MM LOT. (K170452) 2434184: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 MAR 2025. EXPIRATION DATE: 2030-02-16. 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 04.01.0169 GLENOSPHERE - D 36X24.5 (K170452) LOT. 2433118: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MAR 2025. EXPIRATION DATE: 2030-MAR-05. 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 04.01.0400 GRS BASEPLATE - D 24.5X20 - FULL WEDGE 10° (K231911) LOT. 2339036: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 OCT 2024. EXPIRATION DATE: 2029-10-07. 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. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ABOUT 8 MONTHS AFTER PRIMARY SURGERY DUE TO INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, THEN REVISED THE METAPHYSIS, LINER, AND GLENOSPHERE TO IMPLANTS OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519510 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2429766 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention