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

Catalog Number 204-0906

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

Patient Problem Joint Dislocation (2374)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

Revision occurred 2 months after the primary surgery for dislocation of an unknown cause.No actual, implied, or suspect link to fx product.

Event Description

Revision occurred approximately 2 months after the primary surgery which occurred on (b)(6) 2022.No fall or other trauma reported.Revision occurred due to dislocation of unknown cause.40 mm + 6 stability humeral cup explanted and replaced with 40 mm + 9 humeral stability cup with 9 mm spacer.

• 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: 18987027
• MDR Text Key: 338717203
• Report Number: 3014128390-2024-00018
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037315439
• UDI-Public: 03701037315439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213117
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 204-0906
• Device Lot Number: T1644
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2023
• 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: 62 YR
• Patient Sex: Male