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

Model Number	106-4800
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised on (b)(6) 2022 for the second time due to instability.Details on previous shoulder surgeries are as below: 1st revision: (b)(6) 2021 (mdr 3014128390-2021-00053).Primary surgery: (b)(6) 2021.The surgeon explanted a offset head (50x20), 2 pegs glenoid and double taper.A glenoid baseplate (24), centered glenopshere (40), humeral cup (40/3), central screw (12), standard screws (2 of 25 mm each) and locking screws (20 mm and 15 mm).

• Brand Name: HUMERIS ANATOMIC
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 14056600
• Report Number: 3014128390-2022-00013
• Device Sequence Number: 17390225
• Product Code: KWT
• UDI-Device Identifier: 03701037300503
• UDI-Public: 03701037300503
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2022
• Report Date (Section F): 04/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• Device Model Number: 106-4800
• Device Catalogue Number: 106-4800
• Device Lot Number: P0455
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/08/2022