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 Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 06/21/2020

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 300-30-06 - equinoxe preserve stem 6mm : (b)(6).320-01-42 - equinoxe reverse 42mm glenosphere : (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0 : (b)(6).320-15-01 - eq rev glenoid plate : (b)(6).320-15-05 - eq rev locking screw : (b)(6).320-20-00 - eq reverse torque defining screw kit : (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : (b)(6).320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm : (b)(6).321-20-00 - equinoxe reverse shoulder drill kit : (b)(6).(h3) pending evaluation.

Event Description

As reported by the equinoxe shoulder study, the 67-year-old white male patient had a right tsa on (b)(6) 2018.The patient presented with a disassociation of polyethylene - dislocation on (b)(6) 2020.This event is related to (b)(4).The outcome of this event is considered resolved by the action of revision on (b)(6) 2020.The case report form indicates that this event is possibly related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• 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 collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19048156
• MDR Text Key: 339435466
• Report Number: 1038671-2024-00744
• 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
• Type of Report: Initial
• Report Date: 04/04/2024

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 Expiration Date: 01/31/2023
• Device Catalogue Number: 320-42-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2018
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White