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

Model Number 314-0034

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/14/2021

Event Type  Injury  

Event Description

Patient was revised on (b)(6) 2021 due to a cuff tear.No information on the first date of surgery.The surgeon explanted double taper, anchor base, 2 peg glenoid.The surgeon implanted excentered glenosphere, two cortical screw, two locking screw, two standard screw, post extension, stem size 12 and ø36+3 cup.

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.

• Brand Name: EASYTECH ANATOMIC
• Type of Device: TOTAL 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: 13234889
• MDR Text Key: 283665095
• Report Number: 3009532798-2021-00254
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 03701037301470
• UDI-Public: 03701037301470
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/07/2022

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 Model Number: 314-0034
• Device Catalogue Number: 314-0034
• Device Lot Number: N2571
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/12/2022
• 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