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

Catalog Number	105-0026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision occurred on (b)(6) 2026 approximately 392 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 ta6v cementless glenoid baseplate w/peg ti/ha ø24mm, +6mm lateralized, humelock reversed centered glenosphere w/ screw cocr/ta6v 10° tilt ø36mm, humeral cup standard pe/ta6v ø36/+3, two standard screw ta6v ø4.5mm l.30mm and two standard screw ta6v ø4.5mm l.25mm was explanted due to dislocation and replaced with offset taper adapter ta6v ø24 / ø10 and centered head 50x21.Fx v135® humelock stem ta6v ø32/08 l.120mm cementless ti/h was not replaced.
Additional Manufacturer Narrative
Revision occurred approximately 392 days after the primary surgery due to dislocation of unknown cause.No actual, implied, or suspect link to fx products.

• 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 ; 8002800775
• MDR Report Key: 25781576
• Report Number: 3014128390-2026-00033
• Device Sequence Number: 9608059
• Product Code: PHX
• UDI-Device Identifier: 03701037316795
• UDI-Public: 03701037316795
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K210790
• 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): 07/10/2026

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: 105-0026
• Device Lot Number: T0742
• 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: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2022
• 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- V1325; PART- 105-3610 LOT- V1736; PART- 109-4525 LOT- V2687 QTY- 2; PART- 109-4530 LOT- V2689 QTY- 2
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown