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

Model Number	317-4014
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had undergone a primary surgery on (b)(6) 2021 and a revision surgery on (b)(6) 2021 due to infection.All the fx products implanted during the primary surgery on (b)(6) 2021 were explanted and an antibiotic spacer from another manufacturer was implanted.Later, the patient was revised for the second time on (b)(6) 2021, during which the antibiotic spacer was explanted and the fx products 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: 13347705
• Report Number: 3014128390-2022-00001
• Device Sequence Number: 13871804
• Product Code: PHX
• UDI-Device Identifier: 03701037303788
• UDI-Public: 03701037303788
• 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: 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): 01/25/2022
• Report Date (Section F): 01/25/2022

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 Expiration Date: 07/01/2024
• Device Model Number: 317-4014
• Device Catalogue Number: 317-4014
• Device Lot Number: N1590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/25/2022