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

Model Number	316-0012
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/28/2023
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 an infection on (b)(6) 2023.The implantation date was on (b)(6) 2023.A cup, a glenosphere, a metaglene and a stem were explanted.A cup, a glenosphere, a metaglene, screws and a stem were 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: 17265812
• Report Number: 3009532798-2023-00055
• Device Sequence Number: 6058451
• Product Code: PHX
• UDI-Device Identifier: 03701037301579
• UDI-Public: 03701037301579
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/04/2023

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 Model Number: 316-0012
• Device Catalogue Number: 316-0012
• Device Lot Number: T2613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/06/2023
• 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: Hospitalization
• Patient Sex: Unknown