MAUDE Adverse Event Report: FX SOLUTIONS EASYTECH; SHOULDER PROSTHESIS

Model Number 3-4 PEGS GLENOID PE CEMENTED SIZE S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2021

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

The event was a revision surgery due to cuff tear that occured approximately 6 months after the primary surgery.The primary surgery used the easytech anatomical system.The surgeon converted it to a reversed system.He explanted the size s/ 4 pegs glenoid, the 43 x 16 centered head and the +0mm double taper.Then he implanted a 36/+3 135/145 humeral cup, a 24 baseplate, a 36 glenosphere and associated screws.

• 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: ratsamy thevenin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11892123
• MDR Text Key: 252893675
• Report Number: 3009532798-2021-00064
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037301708
• UDI-Public: 03701037301708
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K163669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3-4 PEGS GLENOID PE CEMENTED SIZE S
• Device Catalogue Number: 400-1102
• Device Lot Number: N2543
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• 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