MAUDE Adverse Event Report: FX SOLUTIONS EASYTECH REVERSED; ANATOMIC SHOULDER PROSTHESIS

Catalog Number 324-0803

Device Problem Unstable (1667)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2021

Event Type  Injury  

Manufacturer Narrative

The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.

Event Description

Patient was revised on (b)(6) 2021 due to instability, approximately 8 months after the first surgery.The surgeon explanted 40+3 cup and implanted 135/145 ° 40+9 cup.

• Brand Name: EASYTECH REVERSED
• Type of Device: ANATOMIC SHOULDER PROSTHESIS
• 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: 13087619
• MDR Text Key: 282774315
• Report Number: 3009532798-2021-00224
• Device Sequence Number: 1
• Product Code: PKC
• 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: 12/27/2021

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 Expiration Date: 04/01/2024
• Device Catalogue Number: 324-0803
• Device Lot Number: M1492
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/27/2021
• 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