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

Catalog Number 104-0806

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 03/25/2024

Event Type  Injury  

Event Description

Revision occurred approximately 7 weeks after the primary surgery which occurred on (b)(6) 2024.The system is a hybrid of fx v135 stem and cup on the humeral side and a competitor's products on the glenoid side.No fall or other trauma reported.Revision occurred due to dislocation of unknown cause.40 mm + 6 standard humeral cup explanted and replaced with 40 mm + 9 stability humeral cup.

Manufacturer Narrative

Patient dislocated a month after primary surgery which was a hybrid surgery of fx and competitor product.No actual, implied, or suspect link to fx product.

• Brand Name: FX V135 REVERSED
• Type of Device: 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: 19053586
• MDR Text Key: 339552409
• Report Number: 3014128390-2024-00021
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300138
• UDI-Public: 03701037300138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/05/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 104-0806
• Device Lot Number: U0790
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male