MAUDE Adverse Event Report: FX SOLUTIONS; REVERSED SHOULDER PROTHESIS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Implant Pain (4561)

Event Date 11/23/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient will be revised due to pain (revision for correction) on (b)(6) 2023.The implantation date unknown.The patient will be revised because the prosthesis is too high (the cut made by the surgeon is too high) and the joint is too tight.

• 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: 18028097
• MDR Text Key: 326791269
• Report Number: 3009532798-2023-00102
• Device Sequence Number: 1
• Product Code: PHX
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2023
• 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