MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS FX V135 LONG STEM REVERSED; REVERSE SHOULDER PROSTHESIS

Catalog Number	204-0909
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred after 12 days due to infection.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 12 days after the prior 2nd revision surgery, which occurred on (b)(6) 2025.The primary surgery occurred on (b)(6) 2024, and the 1st revision occurred on (b)(6) 2025.Both prior revisions occurred due to patient non-compliance.No fall or other trauma reported.Revision occurred due to infection at the implant site, 40 mm + 9 humeral stability cup and 9 mm spacer explanted.These items were replaced with identical parts.

• Brand Name: FX V135 LONG STEM REVERSED
• Common Device Name: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison TX 75001
• Manufacturer (Section G): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison TX 75001
• Manufacturer Contact: tristan mahler ; 15920 addison road; addison, TX 75001 ; 7137326920
• MDR Report Key: 22107655
• Report Number: 3014128390-2025-00030
• Device Sequence Number: 8149853
• Product Code: PHX
• UDI-Device Identifier: 03701037315446
• UDI-Public: 03701037315446
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K213117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 05/29/2025

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: 204-0909
• Device Lot Number: U1018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/29/2025
• 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: 203-0007 LOT: V1180
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown