MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM GLENOID BASEPLATE - Ø27X25

Model Number	04.01.0155
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20-october-2025: reverse shoulder system 04.01.0155 glenoid baseplate - ø27x25 (k170452) lot 2201537: (b)(4) items manufactured and released on 25-may-2022 expiration date: 2027-05-11.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 clinical affairs department: revision performed nearly one year after the previous surgical intervention.The patient presented with persistent pain, and radiographic evaluation revealed that the baseplate and glenosphere were positioned suboptimally.This marks the third revision following the initial shoulder arthroplasty in (b)(6) 2024, with prior revisions addressing excessive lateralization and a subsequent infection.It is important to consider that each surgical procedure can significantly alter the anatomical and biomechanical environment of the shoulder joint.Repeated revisions may lead to progressive compromise of the glenoid bone stock and soft tissue envelope, which in turn can affect the ability to achieve stable and accurate implant positioning.Although the precise cause of the malposition remains undetermined, the cumulative impact of prior surgeries likely contributed to a more challenging fixation scenario, increasing the risk of suboptimal alignment of the baseplate and glenosphere.There is no reason to suspect a faulty device.
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2024.On (b)(6) 2024, the patient came in reporting tightness.The surgeon chose to decrease lateralization, by revising the lateralized glenosphere to a standard glenosphere.The surgeon also revised the liner and the surgery was completed successfully.Mdr 3005180920-2024-00640.On (b)(6) 2024, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised all medacta hardware and reimplanted permanent product.The surgery was completed successfully.Mdr 3005180920-2024-00885.On (b)(6) 2025, the patient came in reporting pain and the cause is unknown.The surgeon observed that the baseplate, and consequently the glenosphere, were malpositioned and the cause is unknown.The surgeon revised the medacta metaphysis and liner to medacta components and revised the medacta baseplate and glenosphere to competitor components.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE - Ø27X25
• 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: 23532109
• Report Number: 3005180920-2025-01067
• Device Sequence Number: 9083486
• Product Code: PHX
• UDI-Device Identifier: 07630040706421
• UDI-Public: 07630040706421
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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: 04.01.0155
• Device Lot Number: 2201537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2022
• 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