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

Model Number 314-0030

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 10/28/2021

Event Type  Injury  

Event Description

Patient was revised on (b)(6) 2021 due to a cuff tear, approximately 2 years after the first surgery.Surgeon explanted double taper, excentred head and anchor base.Surgeon implanted standard screw, centered glenosphere, stem ta6v ø36/08, two cortical screw, post extension, humeral cup 36+9 and glenoid baseplate.

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
• 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: 12922648
• MDR Text Key: 281661235
• Report Number: 3009532798-2021-00180
• Device Sequence Number: 1
• Product Code: PKC
• UDI-Device Identifier: 03701037301463
• UDI-Public: 03701037301463
• 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
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2021

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 Model Number: 314-0030
• Device Catalogue Number: 314-0030
• Device Lot Number: L3084
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 12/03/2021
• 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