MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 10MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 300-30-10

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/20/2023

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 84-year-old female patient had an initial right tsa on (b)(6) 2023 and presented with humeral fracture (midshaft), on (b)(6) 2023.Intra-op periprosthetic humeral midshaft fracture requiring orif.The outcome of this event is considered continuing, and the action taken was orif.The case report form indicates that this event is unlikely related to the device and definitely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

Manufacturer Narrative

(h3) pending evaluation.(d10) concomitant device(s): 314-13-13 - equinoxe cage glenoid medium, beta: 4256913.300-50-45 - 4.5mm short rep plate: 5416244.310-01-47 - equinoxe, humeral head short, 47mm (beta): 5193690.315-35-00 - glnd kwire: 5665042.300-20-02 - equinox square torque define screw drive kit: 5442999.

• Brand Name: EQUINOXE PRESERVE STEM 10MM
• 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: 18763770
• MDR Text Key: 336050974
• Report Number: 1038671-2024-00311
• Device Sequence Number: 1
• Product Code: PHX
• 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: 02/22/2024

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 Operator: Health Professional
• Device Catalogue Number: 300-30-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2018
• 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: SEE H10
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian