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

Model Number	400-1101
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed for a conversion from anatomic to reverse configuration due to rotator cuff failure.A size 41 head along with the double cone taper and the glenoid poly were explanted.A 24mm glenoid baseplate, 36 mm glenosphere, 135/145 humeral cup size 36/+ 3, locking screws size 20mm & 30 mm and a standard screw size 30 mm were implanted.

• Brand Name: HUMERIS SHOULDER
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 13095063
• Report Number: 3014128390-2021-00070
• Device Sequence Number: 14375854
• Product Code: HSD
• UDI-Device Identifier: 03701037301692
• UDI-Public: 03701037301692
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2021
• Report Date (Section F): 12/28/2021

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: 05/01/2023
• Device Model Number: 400-1101
• Device Catalogue Number: 400-1101
• Device Lot Number: M0956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/28/2021