MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-46-00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 300-30-12 - equinoxe preserve stem 12mm: 5126770, 320-10-00 - equinoxe reverse tray adapter plate tray +0: 5171492, 320-01-46 - equinoxe reverse 46mm glenosphere: 5155113, 320-15-01 - eq rev glenoid plate: 5185523, 320-15-05 - eq rev locking screw: 5125547, 320-20-00 - eq reverse torque defining screw kit: 5080453, 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: 4981000, 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: 5171677, 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: 5087666, 321-20-00 - equinoxe reverse shoulder drill kit: 5153789, (h3) pending evaluation.

Event Description

As reported by the equinoxe shoulder study, the patient had a left tsa on (b)(6) 2018 and presented with disassociation of polyethylene, on (b)(6) 2019, patient reached back and had a sharp pain.The outcome of this event is considered resolved on (b)(6) 2021.The action taken was revision-standard reverse with the removal of the torque screw, humeral tray, humeral liner, glenosphere, glenosphere locking screw.The case report form indicates that this event is possibly related to the device and definitely not related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: EQUINOXE REVERSE 46MM HUMERAL LINER +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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18862796
• MDR Text Key: 337183002
• Report Number: 1038671-2024-00436
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2022
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2017
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White