MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 06/25/2022

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: serial number item number and full description: (b)(4) - equinoxe preserve stem 6mm (b)(4) - glenosphere, 36mm (b)(4) - small superior augment glenoid plate (b)(4) - 145-deg pe 36mm hum liner +2.5 additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported via a clinical equinoxe shoulder study, that a 65 yo female patient, initial right shoulder implanted on (b)(6)2022, had increased onset of pain posteriorly with no mechanism of injury reported.A scapular spine fracture, (type 2), was indicated.Date of onset was (b)(6)2022.The patient underwent a bone density test.They were prescribed a sling, rest, tramadol, calcium and vitamin d supplements.The study indicated the event was definitely related to the device and the procedure.The outcome states resolved on august 7, 2023.The scapular spine stress fracture is still visible on x-ray, declared nonunion, and the patient is pain free and functioning at a baseline once again.No further information.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17608520
• MDR Text Key: 321803150
• Report Number: 1038671-2023-02034
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• Date Device Manufactured: 08/23/2021
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White