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

Model Number	103-1006
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 due to pain.Approximately 1 years after the last surgery.The surgeon explanted 1 glenoid baseplate (24), 1 centered glenosphere (36), 2 standard screw (20), 2 standard screw (25) and 1 humeral cup (36/6).The surgeon implanted 1 post extension (6), 1 glenoid baseplate (24), 1 eccentric glenosphere (36), 1 humeral cup (36/3), 1 humeral spacer (9), 2 standard screw (30) and 2 standard screw (25).
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number 3014128390-2022-00024.

• Brand Name: HUMELOCK REVERSED
• Common Device Name: REVERSED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: ratsamy thevenin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 14116820
• Report Number: 3009532798-2022-00105
• Device Sequence Number: 2427574
• Product Code: PHX
• UDI-Device Identifier: 03701037309421
• UDI-Public: 03701037309421
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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
• Device Expiration Date: 01/07/2025
• Device Model Number: 103-1006
• Device Catalogue Number: 103-1006
• Device Lot Number: N3270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown