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

Catalog Number	318-3214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred 1 day after the primary surgery due to a periprosthetic fracture that occurred as a complication of patient condition.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 1 day after the primary surgery, which occurred on (b)(6) 2025.No fall or other trauma reported.Revision occurred due to a periprosthetic fracture that likely occurred during the primary implantation of the 70 mm stem.The patient presents with poor bone quality.A 32/14 mini stem and 36 mm + 3 standard humeral cup was explanted.These parts were replaced by a 32/08 120 mm system stem and 36 mm + 3 standard humeral cup.The surgeon has stated that he plans to adjust his technique in cases such as this, using more conservative measures to prevent the forces that caused the fracture.

• 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: 22029841
• Report Number: 3014128390-2025-00023
• Device Sequence Number: 20920525
• Product Code: PHX
• UDI-Device Identifier: 03701037315156
• UDI-Public: 03701037315156
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

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: 318-3214
• Device Lot Number: V1764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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: 103-0803 LOT: V0398
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown