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

Catalog Number	400-1103
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred approximately 364 days after the primary surgery due to loosening of unknown cause.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred on (b)(6) 2026 approximately 364 days after the primary which occurred on (b)(6) 2025.No fall or other trauma was reported.Based on comparing usage forms, only 3-4 pegs glenoid pe cemented size m, centered head 46x15 and double taper ta6v +0mm 0° was explanted due to loosening and replaced with centered head 46x15 and double taper ta6v +0mm 0°.Easytech anchor base ta6v ø38 mm cementless ti/ha was not replaced.

• Brand Name: EASYTECH
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; suite 200; addison TX 75001
• Manufacturer (Section G): FX SHOULDER SOLUTIONS; 15920 addison road; addison TX 75001
• Manufacturer Contact: seenath kabeer ; 15920 addison road; suite 200; addison, TX 75001 ; 8002800775
• MDR Report Key: 25601374
• Report Number: 3014128390-2026-00030
• Device Sequence Number: 5369524
• Product Code: KWT
• UDI-Device Identifier: 03701037301715
• UDI-Public: 03701037301715
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K163669
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 400-1103
• Device Lot Number: U3308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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: 112-0000 LOT: V1419.; PART: 206-4602 LOT: U2884.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown