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

Catalog Number	115-3610
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	12/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred after 8 months due to infection of unknown cause.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 8 months after the primary surgery, which occurred on (b)(6) 2025.No fall or other trauma reported.Revision occurred due to infection at implant site.A 36 mm centered glenosphere, 36 mm + 6 standard humeral cup, 2 standard screws, and 2 locking screws were explanted.These items were replaced with a 36 mm centered glenosphere, 36 mm + 9 stability humeral cup, and 4 locking screws.

• Brand Name: FX V135 MINI 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: 24167400
• Report Number: 3014128390-2026-00003
• Device Sequence Number: 18539356
• Product Code: PHX
• UDI-Device Identifier: 03701037300800
• UDI-Public: 03701037300800
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191146
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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: 115-3610
• Device Lot Number: V1748
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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: 103-0806 LOT: U0856; PART: 108-4520 LOT: V3060; PART: 108-4525 LOT: V2672; PART: 109-4530 LOT: V1959; PART: 109-4535 LOT: V2194
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown