MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOSPHERE - Ø39X27

Model Number	04.01.0173
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 may 2026: lot 2434145: (b)(4) items manufactured and released on 15-apr-2025.Expiration date: 20-mar-2030.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 medacta shoulder r&d project manager: acromion fracture postoperatively, about 11 months post primary.Reason unknown.The surgeon is treated conservatively with physiotherapy and splint/immobilization.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.Additionally, from the radiographic image the bone quality seems low, and this can be also 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.The device history record review did not indicate any potentially related manufacturing issue.The event may be related to case-specific clinical factors, including prosthesis lateralization and/or low bone quality.
Event or Problem Description
Acromion fracture postoperatively, about 11 months post primary.Reason unknown.The surgeon is treated conservatively with physiotherapy and splint/immobilization.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOSPHERE - Ø39X27
• 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: 25297690
• Report Number: 3005180920-2026-00521
• Device Sequence Number: 9249377
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/27/2026

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: 04.01.0173
• Device Lot Number: 2434145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2025
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 85 KG