BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER REVERSE SYSTEM

    MDR report key: 23478279 · Received November 5, 2025

    Report

    Report Number
    3005180920-2025-01089
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 5, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2025. REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE - Ø36X24.5 (K170452) LOT. 2417910: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 NOV 2024. EXPIRATION DATE: 06 NOV 2029. 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 Ø36/+0MM (K170452) LOT. 230753: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 AUGUST 2023. EXPIRATION DATE: 23 JULY 2028. 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. 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

    FOUR MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED BOTH THE LINER AND THE GLENOSPHERE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606202 SHOULDER REVERSE SYSTEM GLENOSPHERE - Ø36X24.5 PHX MEDACTA INTERNATIONAL SA 04.01.0169 2417910 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention