MAUDE Adverse Event Report: FX SOLUTIONS HUMÉRIS ANATOMIQUE; UNCEMENTED SHOULDER PROSTHESIS

Model Number	106-3914
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2022
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 revised on (b)(6) 2022 due to unknown reason.Approximately 1 day after the last surgery.The surgeon explanted 1 double taper and 1 centered head 39.The surgeon implanted 1 eccentric head 43 and 1 centered spacer ø43+3mm.

• Brand Name: HUMÉRIS ANATOMIQUE
• Common Device Name: UNCEMENTED 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: 13937813
• Report Number: 3009532798-2022-00079
• Device Sequence Number: 20031635
• Product Code: HSD
• UDI-Device Identifier: 03701037300381
• UDI-Public: 03701037300381
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111097
• 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): 03/16/2022

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: 07/01/2023
• Device Model Number: 106-3914
• Device Catalogue Number: 106-3914
• Device Lot Number: M1813
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 03/29/2022
• 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