MAUDE Adverse Event Report: FX SOLUTIONS EASYTECH; SHOUDLER PROSTHESIS

Model Number	DIAMETER 43 mm CENTERED
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SHOUDLER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11892151
• Report Number: 3009532798-2021-00055
• Device Sequence Number: 14374060
• 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: 2019
• 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): 05/17/2021

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 05/27/2021
• 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