MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOIDSPHERE 36XØ24.5

Model Number	04.01.0169
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21-05-2025.Lot 2417909: (b)(4) items manufactured and released on 07-11-2024 expiration date: 2029-10-23.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.Acromion stress fracture discovered at about 3 months from the primary rsa in a 83-year-old female patient.From the radiographic image the bone quality seems low and this can be a possible cause of the fracture of the acromion.There is no reason to suspect a malfunctioning device.Patient match planning review shoulder.Our analysis of the myshoulder process of this case found no deviations from the standard procedures.Each step has been performed correctly.Fracture of the acromion is an established complication of reverse shoulder arthroplasty, and it can be related to many factors, both patient-specific and intra-operative.Although a certain root cause cannot be identified, the overall analysis did not reveal any anomalies and there is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
At about 3 months from primary, during postop visit, the surgeon detected an acromion fracture and prescribed physiotherapy and analgesic to the patient.No revision planned.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOIDSPHERE 36XØ24.5
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22209610
• Report Number: 3005180920-2025-00525
• Device Sequence Number: 8262803
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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: 04.01.0169
• Device Lot Number: 2417909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 53 KG