MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS EASYTECH ANATOMIQUE; ANATOMIC SHOULDER PROSTHESIS

Catalog Number	106-4316
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event took place outside the united states (in france) and was associated with a product that is also cleared for the market in the united states.
Event or Problem Description
The patient was revised due to a pain on (b)(6) 2025.The implantation date was on (b)(6) 2024.A centred head and a double taper were explanted.A resurfacing glenoide, a double taper, a centred head were implanted.

• Brand Name: EASYTECH ANATOMIQUE
• Common Device Name: ANATOMIC SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SHOULDER SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: bedrane souad ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 22068334
• Report Number: 3009532798-2025-00035
• Device Sequence Number: 9338127
• Product Code: HSD
• UDI-Device Identifier: 03701037300404
• UDI-Public: 03701037300404
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

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 Expiration Date: 06/01/2024
• Device Catalogue Number: 106-4316
• Device Lot Number: N0410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization
• Patient Sex: Unknown