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

Model Number	DIAMETER 43 mm CENTERED
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The event was a revision surgery due to dislocation that occured approximately a month after the primary surgery.The primary surgery used the easytech anatomical system.During the revision surgery, the surgeon explanted the 43x16mm centered head, the +0mm double taper and the anatomical glenoid.Then, he converted anatomical configuration to a reverse configuration by implanting a ø24 baseplate, a +10mm post extension, a ø36 eccentric glenosphere, a 135/145 ø36/+3 humeral cup and associated screws.

• Brand Name: EASYTECH ANATOMIC
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12452019
• Report Number: 3009532798-2021-00136
• Device Sequence Number: 19134267
• Product Code: HSD
• UDI-Device Identifier: 03701037300404
• UDI-Public: 03701037300404
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: DIAMETER 43 mm CENTERED
• Device Catalogue Number: 106-4316
• Device Lot Number: N0353
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention