MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; REVERSED SHOULDER PROTHESIS

Model Number 314-0909

Device Problem Unstable (1667)

Patient Problem Damage to Ligament(s) (1952)

Event Date 12/28/2022

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitter to fda by the us importer with report number 3014128390-2023-00005.

Event Description

The patient was revised due to shoulder instability on (b)(6) 2022.The implantation date was on (b)(6) 2022.A cementeless glenoid baseplane and a humaral cup were explanted.A centred glenosphere, a humeral cup, cementeless glenoide baseplate were implanted.

• Brand Name: HUMERIS
• Type of Device: REVERSED SHOULDER PROTHESIS
• 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: 16731428
• MDR Text Key: 313201892
• Report Number: 3009532798-2023-00019
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037310519
• UDI-Public: 03701037310519
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 314-0909
• Device Catalogue Number: 314-0909
• Device Lot Number: N1484
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2023
• 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