MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; LAT. GLENOSPHERE 39XØ27

Model Number	04.01.0211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a clinical study, acromion stress fracture discovered at about 9 months from the primary.No revision surgery planned, only physiotherapy prescribed.
Additional Manufacturer Narrative
Batch review performed on 23 december 2024.Lot 2336617: (b)(4) items manufactured and released on 16-jan-2024.Expiration date: 2028-12-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Conclusions: 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.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department acromion stress fracture discovered at about 9 months from the primary rsa.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.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: LAT. GLENOSPHERE 39XØ27
• 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: 21033588
• Report Number: 3005180920-2024-01101
• Device Sequence Number: 4070814
• Product Code: HSD
• UDI-Device Identifier: 07630040728102
• UDI-Public: 07630040728102
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/06/2025

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: 04.01.0211
• Device Lot Number: 2336617
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2024
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 82 KG