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

Model Number EQUINOXE REVERSE 42MM HUMERAL LINER +0

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

Patient Problem Joint Laxity (4526)

Event Date 09/15/2023

Event Type  Injury  

Event Description

It was reported that a male patient, initial left shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2023.The patient dislocated their reverse shoulder due to soft tissue loosening and was revised to a +2.5 42mm humeral liner and a +5 humeral tray.There were no device breakages or surgical delays reported.The patient was last known to be in stable condition following the event.No further information.

Manufacturer Narrative

D10: concomitants: a430775 320-10-00 - equinoxe reverse tray adapter plate tray +0, 6620410 300-01-17 - equinoxe humeral stem primary press fit 17mm, 7105412 320-15-05 - eq rev locking screw, 7193087 320-15-07 - sup/post aug plate, l rs glenoid baseplate, a368649 320-20-00 - eq reverse torque defining screw kit, a384154 320-08-42 - glenosphere exp 42mm +4mm offset, s074352 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, s095185 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, s214272 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, s241702 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.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: kate jacobson ; 3523771140
• MDR Report Key: 17898467
• MDR Text Key: 325251625
• Report Number: 1038671-2023-02476
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 42MM HUMERAL LINER +0
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Date Device Manufactured: 02/10/2022
• 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: Male