MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS HUMELOCK II; REVERSED SHOULDER PROSTHESIS

Catalog Number	314-0703
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised due to disassembly of the cup on (b)(6) 2025.The implantation date was on (b)(6) 2025.A cup, a glenosphere and an offset modular system were explanted.A cup, a glenosphere and an offset modular system were implanted.
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.

• Brand Name: HUMELOCK II
• Common Device Name: REVERSED 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: 22229455
• Report Number: 3009532798-2025-00040
• Device Sequence Number: 15596168
• Product Code: PHX
• UDI-Device Identifier: 03701037301500
• UDI-Public: 03701037301500
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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 Catalogue Number: 314-0703
• Device Lot Number: V1989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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