MAUDE Adverse Event Report: FX SHOULDERS SOLUTIONS DALLAS FX V135 HUMELOCK REVERSED; REVERSE SHOULDER PROSTHESIS

Catalog Number	104-1003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Second revision occurred approximately 21 days after the first revision due to dislocation.The root cause of the problem is unknown.No actual, implied, or suspect link to fx product.
Event or Problem Description
Second revision occurred on (b)(6) 2026, approximately 21 days after the first revision surgery which occurred on (b)(6) 2026.No fall or other trauma reported.Based on comparing usage forms only humeral cup stability pe/ta6v ø40/+3 and humeral spacer ta6v +9mm was explanted due to dislocation of unknown cause.These parts were replaced with humeral cup stability pe/ta6v ø40/+9 and humeral spacer ta6v +9mm.

• Brand Name: FX V135 HUMELOCK REVERSED
• Common Device Name: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDERS SOLUTIONS DALLAS; 15920 addison rd; addison TX 75082
• 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: 24802256
• Report Number: 3014128390-2026-00006
• Device Sequence Number: 15938614
• Product Code: PHX
• UDI-Device Identifier: 03701037309445
• UDI-Public: 03701037309445
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K193394
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: 104-1003
• Device Lot Number: V2100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• 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: 103-0007 LOT: V3091
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown