MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	105-0024
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised on (b)(6) 2022 following the primary surgery on (b)(6) 2021 due to breaking of the screw, baseplate loosening and bone loss.The surgeon explanted the glenoid baseplate (24), centered glenosphere (36), humeral cup (36/3), 2 standard screws (40mm and 15mm) and 2 locking screws (20mm each), retaining the humeris stem (13) and implanted an offset head (54x21) and a centered spacer (5).

• Brand Name: HUMERIS REVERSED
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 13806419
• Report Number: 3014128390-2022-00009
• Device Sequence Number: 11853659
• Product Code: PHX
• UDI-Device Identifier: 03701037300237
• UDI-Public: 03701037300237
• 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): 03/17/2022
• Report Date (Section F): 03/17/2022

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: 03/01/2026
• Device Model Number: 105-0024
• Device Catalogue Number: 105-0024
• Device Lot Number: P1312
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/17/2022