MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE METAPHYSIS +9MM/0°

Model Number	04.01.0111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the patient had primary left shoulder surgery.On (b)(6) 2025, the patient came in reporting a with tight shoulder and limited mobility and the cause is unknown.The surgeon revised the glenosphere, liner, and metaphysis.The surgery was completed successfully (b)(4).On (b)(6) 2025, the patient came in reporting stability issues and the cause is unknown.The surgeon revised the metaphysis and upsized the liner and glenosphere.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 19 november 2025.Lot 2339642a: (b)(4) items manufactured and released on 23-jan-2024.Expiration date: 03-jan-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.Lot 2416294: (b)(4) items manufactured and released on 20-aug-2024.Expiration date: 05-aug-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.Lot 2417916: (b)(4) items manufactured and released on 24-oct-2024.Expiration date: 09-oct-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.Root cause: 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: HUMERAL REVERSE METAPHYSIS +9MM/0°
• 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: 23669504
• Report Number: 3005180920-2025-01200
• Device Sequence Number: 15877970
• Product Code: PHX
• UDI-Device Identifier: 07630040706186
• UDI-Public: 07630040706186
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 11/28/2025

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: 04.01.0111
• Device Lot Number: 2339642A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2024
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White