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

Catalog Number 300-30-06

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 03/07/2022

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0; (b)(6), 320-15-05 - eq rev locking screw; (b)(6), 320-20-00 - eq reverse torque defining screw kit; (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; (b)(6), 320-31-36 - glenosphere, 36mm; (b)(6), 320-35-01 - small glenoid plate; (b)(6), 320-36-00 - 145-deg pe 36mm hum liner +0.

Event Description

It was reported via clinical study that the 57 yo male patient experienced septic loosening.The date of event onset is (b)(6)2021.The patient was revised on (b)(6)2022.Previous: right arthroscopic rotator cuff repair in 2012, 2 additional arthroscopies in 2014.The patient¿s outcome was last known as resolved on (b)(6)2023.

• 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: 17410964
• MDR Text Key: 319924500
• Report Number: 1038671-2023-01801
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• 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: 07/27/2023

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: 300-30-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• 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): Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Race: White