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

Model Number	316-0014
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.
Event or Problem Description
Patient was revised on (b)(6) 2021 for infection, approximately one month after the first surgery.The surgeon explanted stem size 14, centered glenosphere, post extension, 135/145° ø40+3 cup, two locking screw, two screw and glenoid baseplate.The surgeon implanted stem size 14, centered glenosphere, post extension, ø40+9cup, two locking screw, two screw and glenoid baseplate.

• Brand Name: HUMERIS REVERSED
• Common Device Name: REVERSED SHOULDER PROSTHESIS
• 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: ratsamy thevenin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 13083528
• Report Number: 3009532798-2021-00193
• Device Sequence Number: 5346805
• Product Code: PHX
• UDI-Device Identifier: 03701037301593
• UDI-Public: 03701037301593
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2021

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
• Device Expiration Date: 09/01/2025
• Device Model Number: 316-0014
• Device Catalogue Number: 316-0014
• Device Lot Number: N2284A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/24/2021
• 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