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

Catalog Number	314-0038
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised on (b)(6) 2021 due to a dislocation.Approximately 5 months after the first surgery.The surgeon explanted anchor base, humeral cup 135/145 ° ø36+6.The surgeon implanted stem ta6v ø36/14, humeral cup stability 36+3.
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 REVERSED
• 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: 13083949
• Report Number: 3009532798-2021-00206
• Device Sequence Number: 5734535
• Product Code: PKC
• UDI-Device Identifier: 03701037301487
• UDI-Public: 3701037301487
• 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: 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): 12/20/2021

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 Expiration Date: 01/01/2026
• Device Catalogue Number: 314-0038
• Device Lot Number: P1133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/24/2021
• 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