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

Catalog Number	318-3616
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	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred 6 days after the primary surgery due to infection.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 6 days after the primary surgery, which occurred on (b)(6) 2025.No fall or other trauma reported.Revision occurred due to infection at implant site and was a total system explantation.Fx was first alerted to this event on (b)(6) 2025, when following up regarding another revision the patient underwent on (b)(6) 2025, which did not involve fx product.A 36/16 mini system stem, 24 mm glenoid baseplate, 10 mm post extension, 36 mm centered glenosphere, 36 mm + 9 stability humeral cup, 2 locking screws, and 2 standard screws explanted.These items were replaced with a competitor antibiotic spacer.

• 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: 22346504
• Report Number: 3014128390-2025-00041
• Device Sequence Number: 18272699
• Product Code: PHX
• UDI-Device Identifier: 03701037315200
• UDI-Public: 03701037315200
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/27/2025

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: 318-3616
• Device Lot Number: U2528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/27/2025
• 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: 105-0010 LOT: U1678; PART: 105-0024 LOT: U1449; PART: 105-3610 LOT: U1633; PART: 108-4520 LOT: U2974; PART: 108-4530 LOT: U2980; PART: 109-4515 LOT: U2070; PART: 109-4535 LOT: S2300; PART: 203-0909 LOT: S1048
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Unknown