MAUDE Adverse Event Report: FX SOLUTIONS V135; REVERSED SHOULDER PROTHESIS

Model Number 103-0803

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Implant Pain (4561)

Event Date 05/22/2023

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitter to fda by the us importer with report number 3014128390-2023-00013.

Event Description

The patient was revised due to surgical correction ( surgeon choice) on (b)(6) 2023.The implantation date was on (b)(6) 2023.A cup was explanted.A cup was implanted.

• Brand Name: V135
• 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: 17141780
• MDR Text Key: 317292707
• Report Number: 3009532798-2023-00051
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300091
• UDI-Public: 03701037300091
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 103-0803
• Device Catalogue Number: 103-0803
• Device Lot Number: T1405
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2023
• 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