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

Catalog Number	103-1009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred approximately 126 days after the primary surgery due to dislocation of unknown cause.No actaul,implied, or suspect link to fx product.
Event or Problem Description
Revision occurred on (b)(6) 2026, approximately 126 days after the primary surgery which occurred on (b)(6) 2025.No fall or other trauma reported.Humeral cup stability pe/ta6v ø36/+9 and humelock reversed eccentric glenosphere w/ screw cocr/ta6v 10° tilt ø36mm was explanted due to dislocation.These parts were replaced with fx v135 humeral cup 135/145° stability pe/ta6v ø36 +3, humeral spacer ta6v +9mm and humelock reversed eccentric glenosphere w/ screw cocr/ta6v 10° tilt ø36mm.Fx v135® humelock stem ta6v ø36/14 l.120mm cementless ti/ha was not replaced.

• Brand Name: HUMELOCK REVERSED
• Common Device Name: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS; 15920 addison road; addison TX 75001
• Manufacturer (Section G): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison TX 75001
• Manufacturer Contact: seenath kabeer ; 15920 addison road; addison, TX 75001 ; 7137326920
• MDR Report Key: 25060146
• Report Number: 3014128390-2026-00011
• Device Sequence Number: 9426919
• Product Code: PHX
• UDI-Device Identifier: 03701037309438
• UDI-Public: 03701037309438
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193394
• 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): 05/01/2026

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
• Device Catalogue Number: 103-1009
• Device Lot Number: U1195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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: 105-3613 LOT: V2044
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown