MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS HUMERIS; REVERSED SHOULDER PROSTHESIS

Catalog Number	314-0909
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/14/2024
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 glénosphère désassembly on (b)(6) 2024.The implantation date was on (b)(6) 2021.A cup, a glenosphere, and a metaglene were explanted.An helmet head and a double taper were implanted.

• Brand Name: HUMERIS
• 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: 20817109
• Report Number: 3009532798-2024-00128
• Device Sequence Number: 21043508
• Product Code: PHX
• UDI-Device Identifier: 03701037310519
• UDI-Public: 03701037310519
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: 314-0909
• Device Lot Number: U2677
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/02/2024
• 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