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

Catalog Number	316-0010
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event will take place outside the united states (in france) and will be associated with a product that is also cleared for the market in the united states.
Event or Problem Description
The patient will be revised due to an infection on (b)(6) 2023.The implantation date was on (b)(6) 2022.A cup, a glenosphere, a metaglene and a stem may be explanted.A cup, a glenosphere, a metaglene and a stem could be implanted.

• Brand Name: HUMERIS
• Common Device Name: REVERSED SHOULDER PROTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: emeric obin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 17412705
• Report Number: 3009532798-2023-00073
• Device Sequence Number: 15624510
• Product Code: PHX
• UDI-Device Identifier: 03701037301555
• UDI-Public: 03701037301555
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

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: 316-0010
• Device Lot Number: T0850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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