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 Bone Fracture(s) (1870)

Event Date 01/02/2024

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 59-year-old non-hispanic white female had a right tsa (b)(6) 2024.The patient present with humeral fracture ¿ calcar, intra-operatively on (b)(6) 2024.The action of cerclage was taken on (b)(6) 2024 and the outcome of this event is considered resolved.The case report form indicates that this event is definitely not related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

Manufacturer Narrative

(d10) concomitant device(s): 315-35-00 - glnd kwire: a496379, 320-10-00 - equinoxe reverse tray adapter plate tray +0: a810307.320-15-05 - eq rev locking screw: a498615.320-20-00 - eq reverse torque defining screw kit: a757306.320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: a805325.320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: a813553.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: a804367.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: s478973.320-31-36 - glenosphere, 36mm: a812120.320-35-02 - small superior augment glenoid plate: a711662.320-36-00 - 145-deg pe 36mm hum liner +0: a304550.531-20-00 - shldr gps rvrs drill kit: a669039.531-78-20 - shouldr gps hex pins kit: a622224.(h3) pending evaluation.

• 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: matt collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19182269
• MDR Text Key: 341052234
• Report Number: 1038671-2024-00981
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/25/2024

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: 300-30-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2023
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White