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

Model Number	04.01.0173
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Acromial stress fracture occurred approximately 2 months post surgery.
Additional Manufacturer Narrative
Batch review performed on 31 january 2025: lot 2409253: (b)(4) items manufactured and released on 29/08/2024.Expiration date: 07/08/2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.
Additional Manufacturer Narrative
Information included in the follow-up: how the patient was treated, patient primary surgery date corrected, planning review, clinical evaluation, conclusions.Patient match planning review: our analysis of the myshoulder process of this case found no deviations from the standard procedures.Each step has been performed correctly.Clinical evaluation: acromion stress fracture was discovered at about 2 months from the primary rsa.Possible contributing factors could be low bone quality, traumatic events, or even excessive distalization of the implant which increases muscle stress and leads to bone fracture.However, with the information at hand, it is not possible to determine the cause of this fracture but there is no reason to suspect a malfunctioning device.Conclusions: fracture of the acromion is an established complication of reverse shoulder arthroplasty, and it can be related to many factors, both patient-specific and intraoperative.Although a certain root cause cannot be identified, the overall analysis did not reveal any anomalies in the planning and there is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
Acromial stress fracture occurred approximately 2 months post surgery.The patient has not been revised, the surgeon opted for a conservative treatment.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM GLENOSPHERE - Ø39X27
• 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: 21456686
• Report Number: 3005180920-2025-00088
• Device Sequence Number: 7642150
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 04.01.0173
• Device Lot Number: 2409253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 113 KG