BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22506236 · Received July 15, 2025

    Report

    Report Number
    3005180920-2025-00659
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 15, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 JUNE 2025: LOT: 2429372: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JAN-2025. EXPIRATION DATE: 2029-12-19. 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. ADDITIONAL DEVICES REVISED: REVERSE SHOULDER SYSTEM 04.01.0170 GLENOSPHERE - Ø39X24.5 (K170452) LOT: 2430414: BATCH REVIEW PERFORMED ON 30 JUNE 2025: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2025. EXPIRATION DATE: 2030-02-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 45 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 1 MONTH POST-PRIMARY TO JOINT DISLOCATION. THE CAUSE OF THE LUXATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, LINER METAPHYSIS AND DIAPHYSIS WERE REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770650 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM PHX MEDACTA INTERNATIONAL SA 04.01.0123 2429372 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention