MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS FXV135 REVERSE; REVERSE SHOULDER PROSTHESIS

Catalog Number 115-3610

Device Problem Lack of Effect (4065)

Patient Problem Implant Pain (4561)

Event Date 10/30/2023

Event Type  Injury  

Event Description

Revision occurred approx.8 months after primary surgery due to patient pain; primary surgery occurred on (b)(6) 2023.No fall or other trauma noted.36 mm centered glenosphere and 36 mm + 6 standard humeral cup explanted.These parts were replaced with a 32 mm centered glenosphere, 9 mm spacer, 32 mm + 3 humeral cup, and a locking screw.

Manufacturer Narrative

Revision occured 8 months after primary surgery due to patient pain.No actual, implied, or suspect link to fx product.

• Brand Name: FXV135 REVERSE
• 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: 18066446
• MDR Text Key: 327299814
• Report Number: 3014128390-2023-00039
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• 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: T1345
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: 103-0806 LOT: N0268
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR