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

Model Number	04.01.0401
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 jan 2026.Lot: 2315759: (b)(4) items manufactured and released on 24-jun-2024.Expiration date: 2029-jun-06.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.Clinical evaluation performed by clinical affair department.A revision procedure was performed one year after the primary reverse tsa due to migration of the baseplate, which was identified during a routine followup visit.The surgeon revised the construct by implanting a threaded baseplate and replacing the liner with a reverse constrained liner.No device was returned for evaluation, and the poor quality of the available images did not allow confirmation of a definitive root cause.Potential contributing factors & mdash, such as bone quality, initial fixation stability, or patient-specific anatomical considerations cannot be confirmed based on the information provided.However, there is no reason to suspect a malfunctioning device.Root cause: although the specific circumstances involved cannot be confirmed, it is possible that application-specific factors may have resulted in issues reported.The investigation does not indicate any potential manufacturing-related issue or systemic deficiency.
Event or Problem Description
During a post-operation follow up at 1 year from primary, the surgeon discovered that the baseplate had migrated after the patient`s primary left shoulder surgery and the cause is unknown.The surgeon revised the baseplate to a threaded baseplate, the glenosphere and metaphysis to a same size glenosphere and metaphysis, and revised the liner to a reverse constrained liner.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: 24162769
• Report Number: 3005180920-2026-00004
• Device Sequence Number: 13103608
• 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): 01/23/2026

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: 2315759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2024
• 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