MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 6MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 300-30-06

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

Patient Problem Joint Dislocation (2374)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation (d10) concomitant device(s): 320-36-03 - 145-deg pe 36mm hum liner +2.5: 7024581 320-10-05 - equinoxe reverse tray adapter plate tray +5: 7014659 320-31-36 - glenosphere, 36mm: 7082477 320-35-01 - small glenoid plate: 7033340.

Event Description

As reported by the equinoxe shoulder study, the patient had an initial left tsa on (b)(6)2021.The patient presented on (b)(6) 2023 with instability / subluxation.Patient states 4-5 episodes of subluxation over last few months.The case report form indicates that this event is definitely not related to device and/or to procedure.Outcome is resolved by revision on (b)(6) 2023.No device return anticipated due to being a clinical trial study.

• Brand Name: EQUINOXE PRESERVE STEM 6MM
• 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: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18418934
• MDR Text Key: 331605773
• Report Number: 1038671-2023-03074
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• 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: 12/29/2023

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: 300-30-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2021
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White