MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS ANATOMIC; ANATOMIC SHOULDER PROSTHESIS

Model Number 106-3900

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/23/2022

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 cuff tear.Approximately 3 years after the first surgery.The surgeon explanted 1 eccentric head, 1 double taper and 1 2 pegs glenoid.The surgeon implanted 1 glenoid baseplate, 1 post-extension, 3 standard screw, 1 humeral cup 135/145° ø36+3, 1 locking screw and 1 centered glenosphere.

• Brand Name: HUMERIS ANATOMIC
• Type of Device: ANATOMIC 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: 13994503
• MDR Text Key: 288479504
• Report Number: 3009532798-2022-00095
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300466
• UDI-Public: 03701037300466
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2022

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: 01/07/2023
• Device Model Number: 106-3900
• Device Catalogue Number: 106-3900
• Device Lot Number: M1057
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/04/2022
• 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