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

Catalog Number 300-30-12

Device Problem Separation Problem (4043)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: (b)(6), 320-01-42 - equinoxe reverse 42mm glenosphere, (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6), 320-15-03 - rs glenoid plate l post aug, 8 deg, left, (b)(6), 320-42-03 - equinoxe reverse 42mm humeral liner.

Event Description

It was reported via clinical study, that approximately 3 years postop the initial implant, this 77 yo male patient was revised due to disassociation of polyethylene.The patient¿s outcome was last known as continuing.The case report form indicates this event is definitely related to device and definitely related to procedure.Devices will not be returned.

• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17553188
• MDR Text Key: 321226308
• Report Number: 1038671-2023-01954
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10885862515803
• UDI-Public: 10885862515803
• 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: 08/15/2023

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: 300-30-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2018
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White