MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS FXV 135 REVERSED; REVERSE CONFIGURATION SHOULDER PROSTHESIS

Catalog Number	105-4010
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	01/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred after 7 weeks due to infection at implant site.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 7 weeks after the prior revision, which occurred on (b)(6) 2024.The primary surgery occurred on (b)(6) 2023.No fall or other trauma reported.Revision occurred due to infection.40 mm centered glenosphere, and 40 mm + 9 humeral stability cup explanted.These parts were replaced with a 40 mm centered glenosphere, 40 mm + 9 humeral stability cup, and 9 mm spacer.

• Brand Name: FXV 135 REVERSED
• Common Device Name: REVERSE CONFIGURATION 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: 21327250
• Report Number: 3014128390-2025-00007
• Device Sequence Number: 7865719
• Product Code: PHX
• UDI-Device Identifier: 03701037300305
• UDI-Public: 03701037300305
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K150488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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 Expiration Date: 11/01/2023
• Device Catalogue Number: 105-4010
• Device Lot Number: M1326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2018
• 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: 104-1009 LOT: S0175
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male