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

Catalog Number	314-0038
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred approximately 147 days after the primary surgery due to instability of unknown cause.No actual,implied, or suspect link to fx product.
Event or Problem Description
Revision surgery occurred on (b)(6) 2026.All required information was received on 13 may 2026.The revision occurred approximately 147 days after the primary surgery which occurred on 11-sep-2025.No fall or other trauma reported.Based on comparing usage forms only easytech anchor base ta6v ø38 mm cementless ti/ha, 3-4 pegs glenoid pe cemented size xs, double taper ta6v +0mm 0°, and centered head cocr/tin 46x17 was explanted due to instability.These parts were replaced with humelock reversed ta6v cementless glenoid baseplate w/peg ti/ha ø24mm, +3mm lateralized, humelock reversed centered glenosphere w/ screw cocr/ta6v/tin 10° tilt ø36mm, two locking screw ta6v ø4.5mm l.35mm, locking screw ta6v ø4.5mm l.30mm and humeral cup 135/145° stability pe/ta6v ø36 +3.

• Brand Name: EASYTECH
• Common Device Name: ANATOMIC
• Manufacturer (Section D): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; suite 200; addison TX 75001
• Manufacturer (Section G): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; suite 200; addison TX 75001
• Manufacturer Contact: seenath kabeer ; 15920 addison road; suite 200; addison, TX 75001 ; 7137326920
• MDR Report Key: 25234680
• Report Number: 3014128390-2026-00016
• Device Sequence Number: 10183624
• Product Code: PKC
• UDI-Device Identifier: 03701037301487
• UDI-Public: 03701037301487
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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 Catalogue Number: 314-0038
• Device Lot Number: V1722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PART: 112-0000 LOT: V1421.; PART: 116-4617 LOT: V1394.; PART: 400-1101 LOT: V1191.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown