MAUDE Adverse Event Report: FX Shoulder Solutions Dallas FX V135; shoulder prosthesis

Catalog Number	103-1003
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision occurred on (b)(6) 2026 approximately after 14 days after the primary surgery which happened on (b)(6) 2026.No fall or trauma was reported.Based on comparing usage forms humeral cup stability pe/ta6v ø36/+3 and fx v135 humeral spacer ta6v +9mm was explanted due to cup and spacer disassociated from stem.This part was replaced with humeral cup standard pe/ta6v ø36/+3 and humeral spacer ta6v +9mm.Fx v135® humelock stem ta6v ø36/10 l.120mm cementless ti/hawas not replaced.
Additional Manufacturer Narrative
Revision occurred approximately 14 days after the primary surgery due to disassembly.No actual, implied, or suspect link to fx product.

• Brand Name: FX V135
• Common Device Name: 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 ; +1(800)280-0775
• MDR Report Key: 50756685
• Report Number: 3014128390-2026-00046
• Device Sequence Number: 9668616
• Product Code: HSD
• UDI-Device Identifier: 03701037309414
• UDI-Public: 03701037309414
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 103-1003
• Device Lot Number: W1039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2025
• 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 No: 203-0007, Lot No: W2891.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown