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

Model Number 312-0903

Device Problem Unstable (1667)

Patient Problem Damage to Ligament(s) (1952)

Event Date 12/19/2022

Event Type  Injury  

Event Description

The patient was revised due to shoulder instability on (b)(6) 2022.The implantation date was on (b)(6) 2022.A humeral cup were explanted.A humeral cup were implanted.

Manufacturer Narrative

This mdr has alredy been submitter to fda by the us importer with report number 3014128390-2023-00003.

• 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: 16731504
• MDR Text Key: 313202116
• Report Number: 3009532798-2023-00020
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037310618
• UDI-Public: 03701037310618
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 312-0903
• Device Catalogue Number: 312-0903
• Device Lot Number: N2323
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 04/13/2023
• 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