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

Catalog Number 105-3610

Device Problem Lack of Effect (4065)

Patient Problem Implant Pain (4561)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

Patient revised approximately 12 months after primary surgery for pain of unknown subcause.No actual, suspect, or implied link to fx product.

Event Description

Patient revised approximately 12 months after primary surgery, which occurred on (b)(6) 2022.Patient complained of pain.No fall or other trauma noted.36 mm centered glenosphere and 36 mm + 3 standard humeral cup explanted and replaced with a 32 mm eccentric glenosphere, 32 mm + 9 standard humeral cup, and 9 mm humeral spacer.

• Brand Name: FX V135 REVERSED
• Type of Device: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS DALLAS; 13465 midway rd; suite 100 & 101; dallas TX 75244
• Manufacturer (Section G): FX SHOULDER SOLUTIONS DALLAS; 13465 midway rd; suite 100 & 101; dallas TX 75244
• Manufacturer Contact: tristan mahler ; 13465 midway rd; suite 100 & 101; dallas, TX 75244 ; 7137326920
• MDR Report Key: 18375018
• MDR Text Key: 331124328
• Report Number: 3014128390-2023-00044
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300268
• UDI-Public: 03701037300268
• 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: 12/21/2023

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: 105-3610
• Device Lot Number: T1088
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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: 103-0803 LOT: T1254
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR