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

Model Number	314-0030
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised on (b)(6) 2021 due to a cuff tear, approximately 2 years after the first surgery.Surgeon explanted double taper, excentred head and anchor base.Surgeon implanted standard screw, centered glenosphere, stem ta6v ø36/08, two cortical screw, post extension, humeral cup 36+9 and glenoid baseplate.
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.

• Brand Name: EASYTECH
• Common Device Name: TOTAL ANATOMIC 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: 12922648
• Report Number: 3009532798-2021-00180
• Device Sequence Number: 4787378
• Product Code: PKC
• UDI-Device Identifier: 03701037301463
• UDI-Public: 03701037301463
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201391
• 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): 12/01/2021

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 Model Number: 314-0030
• Device Catalogue Number: 314-0030
• Device Lot Number: L3084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown