MAUDE Adverse Event Report: FX SOLUTIONS EASYTECH; SHOUDLER PROSTHESIS

Model Number DIAMETER 43 mm CENTERED

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

The event took place outside of the united states (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 dislocation approximately 2 years after the primary surgery.The primar surgery used the easytech anatomical system.During the revision surgery, the surgeon explanted the 43 x 16 centered head and the +0mm double taper.It was replaced by a reversed configuration.The surgeon implanted a ø24 baseplate, a ø36 centered glenosphere, a ø36/+3 135/145 humeral cup and associated screws.

• Brand Name: EASYTECH
• Type of Device: SHOUDLER 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: 11892151
• MDR Text Key: 266236694
• Report Number: 3009532798-2021-00055
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300404
• UDI-Public: 03701037300404
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111097
• 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: 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 Expiration Date: 11/01/2023
• Device Model Number: DIAMETER 43 mm CENTERED
• Device Catalogue Number: 106-4316
• Device Lot Number: M1823
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2018
• 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