MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS HUMELOCK REVERSED; REVERSE SHOULDER PROSTHESIS

Catalog Number	105-3610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
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 humelock reversed centered glenosphere w/ screw cocr/ta6v 10° tilt ø36 mm and humeral cup standard pe/ta6v ø36/+ was explanted due to instability and replaced with humelock reversed centered glenosphere w/ screw cocr/ta6v 10° tilt ø40 mm and fx v135 humeral cup 135/145° stability pe/ta6v ø40 +6.Fx v135 stem ta6v ø36/16 cementless ti/ha was not replaced.
Additional Manufacturer Narrative
Revision occurred approximately 105 days after the primary surgery due to instability.No actual, implied, or suspect link to fx product.

• Brand Name: HUMELOCK REVERSED
• 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 ; 7137326920
• MDR Report Key: 25488201
• Report Number: 3014128390-2026-00020
• Device Sequence Number: 18624381
• Product Code: PHX
• UDI-Device Identifier: 03701037300268
• UDI-Public: 03701037300268
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150488
• 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: 105-3610
• Device Lot Number: V2745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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: 103-0803 LOT: W0814.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown