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

Catalog Number	318-5210
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	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred due to ifnection after 15 months.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 15 months after the primary surgery, which occurred on (b)(6) 2024.No fall or other trauma reported.Revision occurred due to an infection accompanied by drainage and redness and was a total explant and replacement of the system.A 32/10 120 mm system stem, 24 mm + 6 lateralized baseplate, 32 mm eccentric glenosphere, 32 mm + 6 humeral standard cup, and 6 screws were explanted.These items were replaced with a 32/12 120 mm system stem, 24 mm + 6 lateralized baseplate, 36 mm eccentric glenosphere, 36 mm + 3 135/145* humeral stability cup, and 8 screws.

• Brand Name: FX V135 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: 24069777
• Report Number: 3014128390-2026-00001
• Device Sequence Number: 13358514
• Product Code: PHX
• UDI-Device Identifier: 03701037317891
• UDI-Public: 03701037317891
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K223801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/14/2026

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: 318-5210
• Device Lot Number: U3391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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: 102-0806 LOT: N3251; PART: 105-0030 LOT: V1314; PART: 107-4522 LOT: U3243; PART: 107-4522 LOT: V2076; PART: 108-4530 LOT: U2979; PART: 108-4540 LOT: V0303; PART: 109-4520 LOT: U0919; PART: 109-4530 LOT: P1087; PART: 115-3211 LOT: U2571
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown