MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS FX V135 MINI; REVERSE SHOULDER PROSTHESIS

Catalog Number	115-3210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred approximately 231 days after the primary surgery due to pain.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred on (b)(6) 2026 approximately 231 days after the primary which occurred on (b)(6) 2025.No fall or other trauma was reported.Based on comparing usage forms only humelock reversed centered glenosphere w/ screw cocr/ta6v/tin 10° tilt ø32mm and humeral cup stability pe/ta6v ø32/+9 was explanted due to pain and replaced with fx v135 humeral spacer ta6v +9mm, fx v135 humeral cup 135/145° stability pe/ta6v ø40 +3 and humelock reversed centered glenosphere w/ screw cocr/ta6v/tin 10° tilt ø40mm.Fx v135 stem ta6v ø32/12 cementless ti/ha was not replaced.

• Brand Name: FX V135 MINI
• Common Device Name: REVERSE SHOULDER PROSTHESIS
• 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: 25599056
• Report Number: 3014128390-2026-00028
• Device Sequence Number: 9972489
• Product Code: PHX
• UDI-Device Identifier: 03701037309551
• UDI-Public: 03701037309551
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191146
• 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: 115-3210
• Device Lot Number: V2466
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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: 102-1009, LOT: U1988.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Unknown