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

Model Number EQUINOXE REVERSE 38MM HUMERAL LINER +2.5

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

Patient Problem Insufficient Information (4580)

Event Date 03/25/2022

Event Type  Injury  

Event Description

It was reported that a 60 yo male patient, who had an initial right shoulder implanted on (b)(6) 2020, underwent a revision procedure on (b)(6) 2022, approximately 2 years 2 months post the initial procedure.The patient was revised to a 320-02-38 - rs expanded glenosphere 38mm, +4mm offset, 320-10-10 - equinoxe reverse tray adapter plate tray +10, 320-10-15 - humeral tray +15mm, and a 320-38-03 - 145-deg pe 38mm hum liner +2.5, plus allograft around the proximal humerus.The patient was reported as doing well following the procedure.There were no device breakages or surgical delays indicated.No x-rays or device imaging was provided.No device returns for analysis anticipated.No further information.

Manufacturer Narrative

D10: concomitants: 5603607 - 320-38-03 - equinoxe reverse 38mm humeral liner +2.5.5735062 - 320-15-06 - rs glenoid plate ext cag +10mm cage peg.6170659 - 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.6185251 - 320-38-00 - equinoxe reverse 38mm humeral liner +0.6195096 - 320-01-38 - equinoxe reverse 38mm glenosphere.6226414 - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.6255083 - 320-20-00 - eq reverse torque defining screw kit.6278894 - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.6279192 - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.6293672 - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.6293854 - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.6296548 - 320-10-00 - equinoxe reverse tray adapter plate tray +0.6300909 - 320-15-05 - eq rev locking screw.6301401 - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.

• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18927388
• MDR Text Key: 337944136
• Report Number: 1038671-2024-00546
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2023
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• Device Catalogue Number: 320-38-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Date Device Manufactured: 08/29/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male