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

Catalog Number	318-5414
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision occurred after 3 months due to pain arising from allograft failure.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision occurred approximately 3 months after the primary surgery which occurred (b)(6) 2024.No fall or other trauma reported.Prior revisions had been performed not involving fx.Revision occurred due to pain following failure of allograft prosthesis composite.36/14 120 mm system stem and 40 mm + 9 humeral stability cup explanted.These parts were replaced with a 32/08 180 mm system stem, 49 mm + 3 humeral stability cup, and 4 cortical 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: 20645374
• Report Number: 3014128390-2024-00061
• Device Sequence Number: 17997623
• Product Code: PHX
• UDI-Device Identifier: 03701037317938
• UDI-Public: 03701037317938
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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: 318-5414
• Device Lot Number: U2916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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: 104-1009 LOT: U0590
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female