MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 8MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 300-30-08

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

Patient Problem Bacterial Infection (1735)

Event Date 04/06/2023

Event Type  Injury  

Manufacturer Narrative

Pending evaluation concomitant device(s): 6260438 320-42-03 - equinoxe reverse 42mm humeral liner +2.5.6231759 320-01-42 - equinoxe reverse 42mm glenosphere.6141121 320-10-05 - equinoxe reverse tray adapter plate tray +5.5305446 320-15-07 - sup/post aug plate, l rs glenoid baseplate.

Event Description

As reported by the equinoxe shoulder study, the patient had an initial left tsa on (b)(6)2019.The patient presented in (b)(6) 2021 with septic loosening.Patient noticed progressively worsening shoulder pain and stiffness w/out inciting event.The case report form indicates that this event is definitely not related to device and definitely related to procedure.Outcome was resolved with revision to patient's left shoulder on 06-apr-2023.

• Brand Name: EQUINOXE PRESERVE STEM 8MM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18196995
• MDR Text Key: 328883078
• Report Number: 1038671-2023-02846
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10885862515766
• UDI-Public: 10885862515766
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2023

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: 300-30-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2019
• 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
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Race: White