MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GLENOID RECONSTRUCTION SYSTEM; GRS BASEPLATE - Ø24.5X20 +3MM

Model Number	04.01.0301
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 4 months after the primary, the patient came in presenting instability and the cause was loose baseplate due to poor bone quality.No bone graft used during the primary.The surgeon revised the glenoid, reverse metaphysis to anatomic metaphysis and a sensitin humeral head was placed due to nickel allergy reported by the patient.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06 february 2026.Lot 2344401: (b)(4) items manufactured and released on 05-jun-2024.Expiration date: 2029-05-20.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.

• Brand Name: GLENOID RECONSTRUCTION SYSTEM
• Common Device Name: GRS BASEPLATE - Ø24.5X20 +3MM
• 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: 24482019
• Report Number: 3005180920-2026-00115
• Device Sequence Number: 10125942
• Product Code: PHX
• UDI-Device Identifier: 07630345710307
• UDI-Public: 07630345710307
• Combination Product (Y/N): N
• PMA/510(K) Number: K213459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/02/2026

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: 04.01.0301
• Device Lot Number: 2344401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2024
• 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: Female
• Patient Race: White