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

Model Number	HUMERIS STEM TA6V SIZE 10 CEMENTLESS Ti/HA
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/04/2021
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
The event was a revision surgery due to infection that occured approximately 2 months after the primary surgery.The primary surgery used the humeris reversed system.The surgeon explanted the ø36 centered glenosphere, the ø24 baseplate, the ø36/+3 135/145 humeral cup, the size 10 cementless stem and associated screws.Then he implanted a new glenosphere, a new baseplate, a new humeral cup and a new stem (same new products/same size).He also implanted a 10mm post extension and associated screws.

• Brand Name: HUMERIS
• Common Device Name: REVERSED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12159272
• Report Number: 3009532798-2021-00100
• Device Sequence Number: 4170173
• Product Code: PHX
• UDI-Device Identifier: 03701037301555
• UDI-Public: 03701037301555
• 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): 07/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2025
• Device Model Number: HUMERIS STEM TA6V SIZE 10 CEMENTLESS Ti/HA
• Device Catalogue Number: 316-0010
• Device Lot Number: N2280
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention