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

Catalog Number 115-3610

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

Patient Problem Joint Dislocation (2374)

Event Date 03/18/2024

Event Type  Injury  

Manufacturer Narrative

Revision occurred approximately 7 months after primary surgery with no known cause.No actual, implied, or suspect link to fx product.

Event Description

Revision surgery occurred approximately 7 months after the primary surgery which occurred on (b)(6) 2023.No fall or other trauma reported.Revision occurred for recurrent dislocations of unknown cause.36 mm centered glenosphere, 36 mm + 3 standard humeral cup, and 2 locking screws explanted.These parts were replaced with a 40 mm centered glenosphere, 40 mm + 6 stability humeral cup, 9 mm spacer, and 2 locking screws.

• Brand Name: FX V135 REVERSED
• Type of Device: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison
• 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: 19058861
• MDR Text Key: 339579517
• Report Number: 3014128390-2024-00020
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300800
• UDI-Public: 03701037300800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191146
• 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

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 115-3610
• Device Lot Number: U0193
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2023
• 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
• Treatment: PART: 108-4520 LOT: T1609; PART: 108-4525 LOT: U0368; PART: 203-0803 LOT: T1671
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR