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

Catalog Number	105-0029
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred approximately 56 days after the primary surgery due to loosening.No actual, implied, or suspect link to fx products.
Event or Problem Description
Revision occurred on (b)(6) 2026 approximately 56 days after the primary which occurred on (b)(6) 2026.No fall or other trauma was reported.Based on comparing usage forms humelock reversed ta6v cementless glenoid baseplate w/ screw ti/ha ø24mm, +3mm lateralized and humelock reversed centered glenosphere w/ screw cocr/ta6v/tin 10° tilt ø32mm was explanted due to loosening and replaced with post extension ta6v +10mm cementless ti/ha, locking screw ta6v ø4.5mm l.30mm, fx v135 humeral cup 135/145° standard pe/ta6v ø40 +3, humelock reversed centered glenosphere w/screw cocr/ta6v/tin 10° tilt ø40mm, locking screw ta6v ø4.5mm l.20mm, locking screw ta6v ø4.5mm l.25mm, humelock reversed ta6v cementless glenoid baseplate ti/ha ø24mm and locking screw ta6v ø4.5mm l.30mm.Fx v135® humelock stem ta6v ø32/10 l.120mm cementless ti/ha was not replaced.

• 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: 25765664
• Report Number: 3014128390-2026-00032
• Device Sequence Number: 13396127
• Product Code: PHX
• UDI-Device Identifier: 03701037316801
• UDI-Public: 03701037316801
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210790
• 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): 07/09/2026

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: 105-0029
• Device Lot Number: W2294
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2026
• 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 NO- 115-3210 LOT- W0984
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown