MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GRS BASEPLATE FULL WEDGE 15

Model Number	04.01.0401
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 august 2025.Lot 2339034: (b)(4) items manufactured and released on 23-sept-2024.Expiration date: 06-sept-2029.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: revision after 2,5 months since the previous surgery due to a loose baseplate.This is a second revision, the first one consinsted of a changing from an anatomic to a reverse.A grs full wedge was used in the first revision.From the radiographic image it is visible that the baseplate position is suboptimal, showing the loosening of the baseplate.The surgeon revised the reverse shoulder to a hemi shoulder.These findings suggest poor integration and possible mechanical instability of the glenoid component.In the absence of additional clinical or radiological history, we assume this is a case of aseptic loosening.This is a known adverse event described in literature following primary shoulder arthroplasty, and the exact cause of failure cannot be determined.Conclusions: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient underwent primary surgery on (b)(6) 2025.On (b)(6) 2025, the patient presented with pain due to a failed subscapularis muscle, the cause of which was unknown.The surgeon revised the implant from an anatomic shoulder to a reverse shoulder.The surgery was completed successfully.On (b)(6) 2025, the patient again presented with pain, this time due to a loose baseplate, with the cause remaining unknown.The surgeon revised the reverse shoulder to a hemi shoulder.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GRS BASEPLATE FULL WEDGE 15
• 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: 22922921
• Report Number: 3005180920-2025-00813
• Device Sequence Number: 13335730
• Product Code: PHX
• UDI-Device Identifier: 07630542714634
• UDI-Public: 07630542714634
• 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: 2025
• 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): 08/29/2025

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: 04.01.0401
• Device Lot Number: 2339034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2024
• 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