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

Catalog Number 316-0010

Device Problem Microbial Contamination of Device (2303)

Event Date 08/03/2023

Event Type  Injury  

Manufacturer Narrative

The event will take place outside the united states (in france) and will be associated with a product that is also cleared for the market in the united states.

Event Description

The patient will be revised due to an infection on (b)(6) 2023.The implantation date was on (b)(6) 2022.A cup, a glenosphere, a metaglene and a stem may be explanted.A cup, a glenosphere, a metaglene and a stem could be 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: emeric obin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 17412705
• MDR Text Key: 319928177
• Report Number: 3009532798-2023-00073
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037301555
• UDI-Public: 03701037301555
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 316-0010
• Device Lot Number: T0850
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2023
• 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): Required Intervention; Hospitalization