MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-42-03

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

Patient Problem Failure of Implant (1924)

Event Date 02/16/2024

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 61-year-old white male had a right tsa (b)(6) 2022.The patient present with disassociation of polyethylene on (b)(6) 2024.The patient dislocated shoulder while working out, resulting in disassociation of poly component.The patient underwent revision surgery on (b)(6) 2024.The outcome of this event is considered resolved on (b)(6) 2024.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.

Manufacturer Narrative

(d10) concomitant device(s): 300-30-07 - equinoxe preserve stem 7mm : 6914643.320-02-42 - rs expanded glenosphere 42mm, +4mm offset : 5593172.320-10-00 - equinoxe reverse tray adapter plate tray +0 : 6999112.320-15-01 - eq rev glenoid plate : 6665612.320-15-05 - eq rev locking screw : 7170874.320-20-00 - eq reverse torque defining screw kit : 7178788.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : s297345.320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm : s323144.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm : s058734.321-52-07 - 3.2mm drill bit sterile : 6478784.(h3) pending evaluation.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
• 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: matt ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19181768
• MDR Text Key: 341051020
• Report Number: 1038671-2024-00979
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/25/2024

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: 320-42-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1422-2024
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White