BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 23356473 · Received October 22, 2025

    Report

    Report Number
    3005180920-2025-01025
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 22, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 OCTOBER 2025. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2413114: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2024. EXPIRATION DATE: 2029-09-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED AND REVISED: BATCH REVIEW PERFORMED ON 08 OCTOBER 2025 REVERSE SHOULDER SYSTEM 04.01.0301 GRS BASEPLATE - Ø24.5X20 +3MM (K213459) LOT 2408055: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUNE-2024. EXPIRATION DATE: 2029-06-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 08 OCTOBER 2025 REVERSE SHOULDER SYSTEM 04.01.0116 HUMERAL REVERSE HC LINER Ø32/+0MM (K170452) LOT 2337208: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-NOV-2023. EXPIRATION DATE: 2028-11-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 08 OCTOBER 2025 REVERSE SHOULDER SYSTEM 04.01.0206 LAT. GLENOSPHERE 32XØ24.5 (K193175) LOT 2341013:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JAN-2024. EXPIRATION DATE: 2029-01-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. 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

    AT ABOUT 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO CONTINUOUS PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE SHOULDER FROM A REVERSE SHOULDER TO A HEMI ARTHROPLASTY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241367 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2413114 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention