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

Model Number 314-0706

Device Problem Microbial Contamination of Device (2303)

Event Date 03/22/2023

Event Type  Injury  

Event Description

The patient was revised due to an infection on (b)(6) 2023.The implantation date was on (b)(6) 2023.A cup, a glenosphere, a metaglene and a stem were explanted.A cup, a glenosphere, and screw were implanted.

Manufacturer Narrative

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

• 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: 16680513
• MDR Text Key: 312674232
• Report Number: 3009532798-2023-00016
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037301517
• UDI-Public: 03701037301517
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 314-0706
• Device Catalogue Number: 314-0706
• Device Lot Number: S0402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2023
• 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