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

Model Number	316-0012
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/08/2021
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 patient was operated on (b)(6) 2021 and during the operation the screw heads were broken and the operation lasted 2 hours.This event is the result of a recovery for infection.This revision for infection took place 6 years after the first installation.The surgeon explanted humeris stem size 12, two locking screw, two standard screw, centered glenosphere, 135/145° ø40+3 cup and glenoid base plate.The surgeon implanted humeris stem size 10, two locking screw, two standard screw, centered glenosphere, 135/145° ø40+3 cup and glenoid base plate.

• 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: 13442022
• Report Number: 3009532798-2021-00253
• Device Sequence Number: 2110152
• Product Code: PHX
• UDI-Device Identifier: 03701037301579
• UDI-Public: 03701037301579
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2022

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: 12/30/2019
• Device Model Number: 316-0012
• Device Catalogue Number: 316-0012
• Device Lot Number: I344
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 02/03/2022
• 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