MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; LAT. GLENOSPHERE 36XØ24.5

Model Number	04.01.0207
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 march 2026.Reverse shoulder system 04.01.0207 lat.Glenosphere 36xd 24.5 lot.2402696 (k193175) lot 2402696: 40 items manufactured and released on 17-may-2024.Expiration date: 2029-04-29.No anomalies found related to the problem.To date, 39 items of the same lot have been sold with one similar reported event during the period of review.Reverse shoulder system 04.01.0121 humeral reverse hc liner d 36/+6mm (k170452) lot 2315000: 45 items manufactured and released on 11-sep-2023.Expiration date: 2028-08-27.No anomalies found related to the problem.To date, 38 items of the same lot have been sold with one 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.
Event or Problem Description
The patient had primary anatomic total left shoulder surgery on (b)(6) 2025.On (b)(6) 2025, the patient came in reporting pain after falling and sustaining an acute subscapular failure/dislocation.The surgeon converted the patient from anatomic to reverse.The surgery was completed successfully.Presently, on (b)(6) 2026, the patient came in presenting ongoing instability and the cause is unknown.The surgeon revised the glenosphere from a 36/lat to a 39/lat, and revised the diaphysis, metaphysis and liner to a competitor diaphysis, metaphysis and liner.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: LAT. GLENOSPHERE 36XØ24.5
• 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: 24710834
• Report Number: 3005180920-2026-00246
• Device Sequence Number: 6110348
• Product Code: HSD
• UDI-Device Identifier: 07630040728065
• UDI-Public: 07630040728065
• Combination Product (Y/N): N
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 03/27/2026

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: 04.01.0207
• Device Lot Number: 2402696
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Race: White