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

Catalog Number	400-1104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred approximately 105 days after the primary surgery due to instability.No actual,implied, or suspect link to fx product.
Event or Problem Description
Revision occurred on (b)(6) 2026 approximately 105 days after the primary which occurred on (b)(6) 2026.No fall or other trauma was reported.Based on comparing usage forms, only 3-4 pegs glenoid pe cemented size l and centered head cocr/tin 48x18 was explanted due to instability and replaced with humelock reversed ta6v cementless glenoid baseplate w/ screw ti/ha ø24mm, +3mm lateralized, humelock reversed centered glenosphere w/ screw cocr/ta6v/tin 10° tilt ø36mm, humeral cup 135/145° standard pe/ta6v ø36 +3, central screw ta6v ø4.5mm l.14mm, locking screw ta6v ø4.5mm l.25mm, locking screw ta6v ø4.5mm l.20mm and two locking screw ta6v ø4.5mm l.15mm.

• 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 ; 8002800775
• MDR Report Key: 25491660
• Report Number: 3014128390-2026-00021
• Device Sequence Number: 16032904
• Product Code: KWT
• UDI-Device Identifier: 03701037301722
• UDI-Public: 03701037301722
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K163669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/12/2026

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: 400-1104
• Device Lot Number: U3310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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: 116-4818 LOT: V1396.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown