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

Model Number	313-0709
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised on (b)(6) 2022 due to dislocation following the primary surgery on (b)(6) 2022.The surgeon explanted a humeral cup (36/9) and implanted a reverse adapter and a stability humeral cup (36/6).

• 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: 14056675
• Report Number: 3014128390-2022-00014
• Device Sequence Number: 12005431
• Product Code: PHX
• UDI-Device Identifier: 03701037301371
• UDI-Public: 03701037301371
• 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: 2022
• 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 Model Number: 313-0709
• Device Catalogue Number: 313-0709
• Device Lot Number: M3179
• 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 Sex: Unknown
• Date Report Sent to FDA: 04/08/2022