MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10

Model Number	04.01.0170
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Acromion bone fracture has been detected post-operatively in the patient and the cause is unknown.Physiotherapy has been prescribed and revision surgery is not planned.
Additional Manufacturer Narrative
Batch review performed on 04-mar-2025.Lot 174731d: (b)(4) items manufactured and released on 08-mar-2024.Expiration date: 21-feb-2029.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 medical affairs manager: an acromion stress fracture was detected post-operatively after the primary rsa.A possible contributing factor could be low bone quality or a traumatic event, or even excessive distalization of the implant, which increases muscle stress and leads to bone fracture.However, based on the available information.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: REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10
• 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: 21618134
• Report Number: 3005180920-2025-00205
• Device Sequence Number: 15587434
• Product Code: KWS
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• 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: 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
• Report Date (Section B): 03/17/2025

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 Expiration Date: 03/08/2024
• Device Model Number: 04.01.0170
• Device Lot Number: 174731D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2024
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 65 KG