MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOID BASEPLATE - Ø24.5X25

Model Number	04.01.0152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Acromion fracture detected 5 months after the primary procedure.No revision surgery planned; physiotherapy only.
Additional Manufacturer Narrative
Batch review performed on 02 mar 2026.Reverse shoulder system 04.01.0152 glenoid baseplate - d 24.5x25 (k170452) lot: 2508597: (b)(4) items manufactured and released on 07-jul-2025.Expiration date: 2030-jun-22.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: 2508854: (b)(4) items manufactured and released on 23-jul-2025.Expiration date: 2030-jul-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.Clinical evaluation performed by clinical affairs department.Revision about 5 months after the primary due to a fractured acromium and it is unknown how this occured.The fracture may have happened due to lateralization of the prosthesis, as no traumatic event has been reported, but we have no sufficient data to exclude it.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.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOID BASEPLATE - Ø24.5X25
• 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: 24603552
• Report Number: 3005180920-2026-00219
• Device Sequence Number: 8366604
• Product Code: PHX
• UDI-Device Identifier: 07630040706391
• UDI-Public: 07630040706391
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: 04.01.0152
• Device Lot Number: 2508597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2025
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 73 KG