MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/28/2021

Event Type  Injury  

Event Description

As reported, the patient had an initial left tsa on (b)(6) 2021.The patient presented on (b)(6) 2021 and patient tried to lift a can of soda and felt a pop in the region of her shoulder, increased pain, decreased range of motion.The case report form indicates that this event is definitely not related to device, definitely related to procedure.

Manufacturer Narrative

Pending investigation.D10: 6831218 300-30-08 - equinoxe preserve stem 8mm.6701399 320-35-02 - small superior augment glenoid plate.6352058 320-36-00 - 145-deg pe 36mm hum liner +0.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17781481
• MDR Text Key: 323841587
• Report Number: 1038671-2023-02325
• Device Sequence Number: 1
• Product Code: KWT
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2020
• 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 Sex: Female
• Patient Weight: 59 KG
• Patient Race: White