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	07/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 august 2025.Lot 2246775: (b)(4) items manufactured and released on 06-sep-2023.Expiration date: 2028-ago-21.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 medical affairs department revision 1 year and 8 months after primary rsa due to a loose baseplate.The reason of this event it may be poor integration and possible mechanical instability of the glenoid component and notintegration of the bonegraft.There is no reason to suspect a malfunctioning device.Root cause: implant mobilization is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
The patient had pain due to a loose baseplate and the cause is unknown.At about 1 year and 8 months post primary the surgeon revised the baseplate, glenosphere, screws, liner and metaphysis.The surgery was completed successfully.

• Brand Name: GLENOID RECONSTRUCTION SYSTEM
• Common Device Name: GRS BASEPLATE - Ø24.5X20 +3MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22803542
• Report Number: 3005180920-2025-00781
• Device Sequence Number: 8950781
• Product Code: PHX
• UDI-Device Identifier: 07630345710307
• UDI-Public: 07630345710307
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K213459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: 04.01.0301
• Device Lot Number: 2246775
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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