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

Catalog Number 317-3614

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

Patient was revised 1 month after primary surgery due to lack of following surgical technique during primary surgery.No actual, implied, or suspect link to fx product.

Event Description

Revision was performed approximately 1 month after the primary surgery; primary surgery occurred on (b)(6) 2023.No fall or other trauma noted.Patient presented with a loosened stem within the humeral canal.36x14 stem, 40 mm +3 stability humeral cup, and 9 mm spacer explanted.These parts were replaced with a 40x14 stem, 40 mm + 3 stability humeral cup, 9 mm spacer, a 34 mm cortical screw, and a 28 mm cortical screw.The primary surgery was treatment for a fracture.Contrary to the surgical technique for the primary surgery, the surgeon did not include any distal screws, which allowed the stem to loosen.Surgeon stated that all future proximal humeral fractures will be treated with distal screws.

• Brand Name: HUMELOCK 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: 18187434
• MDR Text Key: 328738849
• Report Number: 3014128390-2023-00042
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037303757
• UDI-Public: 03701037303757
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162455
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 317-3614
• Device Lot Number: S0698
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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: 103-0007 LOT: P1280; PART: 104-1003 LOT: P0821
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male