MAUDE Adverse Event Report: FX SOLUTIONS HUMÉRIS REVERSBILE; REVERSIBLE SHOULDER PROSTHESIS

Model Number	314-0706
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event took place outside of the united states ((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 revised on (b)(6) 2022 due to dislocation.Approximately 3 months after the first surgery.The surgeon explanted 1 stem huméris 10, 1 eccentric glenosphere, 1 humeral cup 40+6 and 1 glenoid baseplate.The surgeon implanted 1 humeral cup 135/145° ø40+3, 1 glenosphere, 1 glenoid baseplate, 1 post extension, 1 stem humelock ii, 2 cortical screw, 1 standard screw and 2 locking screw.

• Brand Name: HUMÉRIS REVERSBILE
• Common Device Name: REVERSIBLE 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: 13994217
• Report Number: 3009532798-2022-00088
• Device Sequence Number: 4452683
• Product Code: PHX
• UDI-Device Identifier: 03701037301517
• UDI-Public: 03701037301517
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 03/23/2022

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: 05/01/2024
• Device Model Number: 314-0706
• Device Catalogue Number: 314-0706
• Device Lot Number: M1439
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/04/2022
• 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