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

Model Number	108-4540
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2021
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 operate on (b)(6) 2021 for unknown reason.The surgeon explanted a locking screw l40mm and no information on the implanted product.

• Brand Name: HUMERIS REVERSED
• Common Device Name: REVERSED SHOULDERS 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: 12982474
• Report Number: 3009532798-2021-00157
• Device Sequence Number: 20159143
• Product Code: PHX
• UDI-Device Identifier: 03701037302118
• UDI-Public: 03701037302118
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150488
• 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): 10/27/2021

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: 02/01/2024
• Device Model Number: 108-4540
• Device Catalogue Number: 108-4540
• Device Lot Number: M3887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 12/13/2021
• 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