MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOID BASEPLATE - Ø27X25

Model Number	04.01.0155
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 mar 2026.Reverse shoulder system 04.01.0155 glenoid baseplate - d 27x25 (k170452) lot.2431977: 52 items manufactured and released on 11-march-2025.Expiration date: 2030-feb-23.No anomalies found related to the problem.To date, 45 items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0173 glenosphere - d 39x27 (k170452) lot.2507897: 120 items manufactured and released on 16-june-2025.Expiration date: 2030-june-02.No anomalies found related to the problem.To date, 109 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: revision at about 3 months from the rsa due to an acromion stress fracture.From the radiographic image, the bone quality seems low, and this can also be the cause of the fracture of the acromion.There is no reason to suspect a malfunctioning device.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.From the x-ray, the bone quality appears to be very poor and may have been a contributing factor to the fracture.
Event or Problem Description
Revision surgery after 3 months post-primary due to an acromium fracture.
Additional Manufacturer Narrative
No revision was performed at the end.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.From the x-ray, the bone quality appears to be very poor and may have been a contributing factor to the fracture.
Event or Problem Description
Acromial fracture occurred three months post-primary and was treated conservatively with immobilization and physiotherapy.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOID BASEPLATE - Ø27X25
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24684871
• Report Number: 3005180920-2026-00231
• Device Sequence Number: 21342647
• Product Code: PHX
• UDI-Device Identifier: 07630040706421
• UDI-Public: 07630040706421
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.01.0155
• Device Lot Number: 2431977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 65 KG