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

Model Number	04.01.0110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had shoulder instability and the cause is unknown.At about 4 months post priamry the surgeon lateralized the glenosphere, swapped the metaphysis, and upsized the poly to improve patient stability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 01 december 2025: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2432569: (b)(4) items manufactured and released on 10-mar-2025.Expiration date: 2030-feb-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.Reverse shoulder system 04.01.0122 humeral reverse hc liner d 39/+0mm (k170452) lot 2501310: (b)(4) items manufactured and released on 14-apr-2025.Expiration date: 2030-apr-07.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.Reverse shoulder system 04.01.0170 glenosphere - d 39x24.5 (k170452) lot 2501157: (b)(4) items manufactured and released on 15-apr-2025.Expiration date: 2030-mar-25.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 +0MM/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: 23694052
• Report Number: 3005180920-2025-01222
• Device Sequence Number: 9082664
• Product Code: PHX
• UDI-Device Identifier: 07630040706179
• UDI-Public: 07630040706179
• 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): 12/02/2025

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: 04.01.0110
• Device Lot Number: 2432569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2025
• 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 Sex: Male
• Patient Race: White