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	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary right shoulder surgery on (b)(6) 2022.On (b)(6) 2023, the patient came in reporting pain due to a malpositioned baseplate and the cause of the malpositioned baseplate is unknown.The surgeon revised the baseplate, glenosphere and liner.The surgery was completed successfully.(b)(4).On (b)(6) 2026, the patient came in reporting pain due to a loose baseplate due to poor bone quality.The surgeon revised the baseplate, the glenosphere and the liner.The surgery was completed successfully.Presently, on (b)(6) 2026 the patient came in reporting pain due to a loose baseplate and the cause is unknown.The surgeon revised the reverse hc liner ø42/+6mm to a rev.Constrained e-cross liner ø42/+0, revised the ø42x24.5 glenosphere to a same size glenosphere, and revised the ø24.5x20 - full wedge 10° baseplate to a same size baseplate.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 2 september 2026.Reverse shoulder system 04.01.0400 grs baseplate - ø24.5x20 - full wedge 10° (k231911) lot 2339042: (b)(4) items manufactured and released on 27-jan-2025.Expiration date: 08-jan-2030.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.Root cause: the event is consistent with aseptic loosening of the glenoid baseplate, which may result from multifactorial clinical and/or mechanical conditions.Humeral impingement against the glenosphere may represent a possible contributing mechanism; however, this cannot be confirmed based on the available information.No device-related root cause or device deficiency has been identified.

• 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, 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: 50946796
• Report Number: 3005180920-2026-00980
• Device Sequence Number: 21419617
• Product Code: PHX
• UDI-Device Identifier: 07630542714627
• UDI-Public: 07630542714627
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K231911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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
• Device Model Number: 04.01.0400
• Device Lot Number: 2339042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/31/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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