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

Model Number 104-0803

Device Problem Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/24/2022

Event Type  Injury  

Manufacturer Narrative

The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.

Event Description

The patient was revised on (b)(6) 2022 due to dismantling.Approximately 22 days after the first surgery.The surgeon explanted 1 glenoid baseplate 24, 1 post extension +6, 3 locking screws, 1 standard screw, 1 centered glenosphere 40 and 1 humeral cup 40+3.The surgeon implanted 1 glenoid baseplate 24, 1 poste extension 10, 2 locking screws 40 and 35, 2 standard screws 40 and 30, 1 centered glenosphere 36 and 1 humeral cup 36+3.

• Brand Name: HUMELOCK REVERSED
• Type of Device: 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: 13652187
• MDR Text Key: 286445888
• Report Number: 3009532798-2022-00064
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300121
• UDI-Public: 03701037300121
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/25/2022

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
• Device Model Number: 104-0803
• Device Catalogue Number: 104-0803
• Device Lot Number: N2349
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization