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

Model Number	105-0024
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised on (b)(6) 2022 for the second time due to notching/pain.The details on previous surgeries are as below 1st revision - (b)(6) 2021 (mdr # 3014128390-2021-00032) primary surgery - (b)(6) 2021.The surgeon explanted a glenoid baseplate (24), centered gelnosphere (36), 2 standard screws (20mm and 25 mm each) and a humeral cup (36/6).A post-extension (6mm), glenoid aseplate (24), eccentric gelnosphere (36), humeral cup (36/3), humeral spacer (9) and 2 standard screws (30mm and 25 mm each) were implanted.

• Brand Name: HUMELOCK REVERSED
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 14196964
• Report Number: 3014128390-2022-00017
• Device Sequence Number: 14822730
• 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): 04/25/2022
• Report Date (Section F): 04/25/2022

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 Model Number: 105-0024
• Device Catalogue Number: 105-0024
• Device Lot Number: P1164
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2022
• 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: 73 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/25/2022