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

Catalog Number 105-0128

Device Problem Migration (4003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 12/16/2022

Event Type  Injury  

Event Description

The patient was revised on (b)(6) 2022 because the glenoid component loosened.The primary surgery was on (b)(6) 2022.Glenoid baseplate, 36 mm centered glenosphere, and 3 screws explanted.These parts were replaced with a 50 mm offset head and centered spacer.

Manufacturer Narrative

Patient revised after 2 weeks for loosening of glenoid component.No actual, implied, or suspect link to fx product.

• Brand Name: HUMERIS REVERSE
• 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: 18903678
• MDR Text Key: 337658669
• Report Number: 3014128390-2024-00015
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037316870
• UDI-Public: 03701037316870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210790
• 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: 03/14/2024

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 Catalogue Number: 105-0128
• Device Lot Number: S2266
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 105-4520 LOT: T1274; PART: 108-4515 LOT: S2284; PART: 108-4515 LOT: T0103; PART: 115-3610 LOT: T1033
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female