MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 15°

Model Number	04.01.0401
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery after 3 months from the primary due to a loose glenoid caused by a suspected infection.The surgeon performed a washout and revised the patient to a hemi.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 14 july 2026 04.01.0401 grs baseplate - d 24.5x20 - full wedge 15° (k231911) lot.2339034: (b)(4) items manufactured and released on 23 september 2024.Expiration date: 06 september 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, the early loosening of the glenoid component may have been associated with the suspected infection.As the infection was not confirmed, no definitive root cause can be established, and there is no indication of a device-related cause.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 15°
• 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: 25813731
• Report Number: 3005180920-2026-00702
• Device Sequence Number: 6038144
• Product Code: PHX
• UDI-Device Identifier: 07630542714634
• UDI-Public: 07630542714634
• Combination Product (Y/N): N
• PMA/510(K) Number: K231911
• 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): 07/14/2026

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: 04.01.0401
• Device Lot Number: 2339034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2024
• 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 Sex: Unknown