MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 10°

Model Number	04.01.0400
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 december 2025 lot 2339036: (b)(4) items manufactured and released on 21-oct-2024.Expiration date: 2029-10-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause:aseptic loosening is a possible literature-described adverse event following shoulder arthroplasties and causes are often unknown.In this case, the loosening likely resulted from poor bone quality and complex anatomical conditions following previous trauma, which limited the potential for osseointegration and mechanical stability.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
At about 6 months after the primary, the patient came reporting pain due to a loose baseplate and the cause is unknown.The surgeon revised the all components except the stem.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 10°
• 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: 23837336
• Report Number: 3005180920-2025-01247
• Device Sequence Number: 4993143
• Product Code: PHX
• UDI-Device Identifier: 07630542714627
• UDI-Public: 07630542714627
• 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): 12/18/2025

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: 04.01.0400
• Device Lot Number: 2339036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2024
• 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: 73 YR
• Patient Sex: Female