MAUDE Adverse Event Report: FX SOLUTIONS EASYTECH; SHOULDER PROSTHESIS

Model Number 314-0034

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

The event took place outside of the united states (in (b)(6)).The anchor base and head were used with a glenoid not available in the us.

Event Description

This event was a revision surgery for total shoulder arthroplasty removal that occured approximately 6 years after the primary surgery.The primary surgery used the easytech anatomic system.During the revision surgery, the surgeon explanted all the components and implanted a new prosthesis from another manufacturer.He explanted the ø34 anchor base, the ø20 resurfacing glenoid, the +0 double taper and the 43x16 centered head.

• Brand Name: EASYTECH
• Type of Device: 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: ludovic badey ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12279174
• MDR Text Key: 265120104
• Report Number: 3009532798-2021-00112
• Device Sequence Number: 1
• Product Code: HSD
• 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
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/04/2021

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 Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: 314-0034
• Device Catalogue Number: 314-0034
• Device Lot Number: I434
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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; Required Intervention