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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2026 lot 2339037: 50 items manufactured and released on (b)(6) 2024.Expiration date: (b)(6) 2029.No anomalies found related to the problem.To date, 43 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by clinical affairs department revision 5 months and a half after the primary surgery, due to pain due to a baseplate that was implanted too superior on the glenoid face during the primary surgery.The liner was changed to a constrained e-cross liner d 36/+0.The medacta stem remained as it was well fixed.The surgery was completed successfully.From the radiographic image it is visible the position of the baseplate which is suboptimal.With the information at hand there is no reason to suspect a malfunctioning device.Root cause:as reported in the form, the device was likely positiined suboptimally at the time of the primary surgery.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 came in presenting pain due to a baseplate that was implanted too superior on the glenoid face during the primary surgery.About 5 months and a half after the primary surgery, the surgeon revised the baseplate and glenosphere to a competitor baseplate and glenosphere, and the liner to a rev.Constrained e-cross liner d 36/+0.The medacta stem remained as it was well fixed.The surgery was completed successfully.

• 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: 25313932
• Report Number: 3005180920-2026-00529
• Device Sequence Number: 16087574
• 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: 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): 05/28/2026

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: 2339037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2024
• 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: Male