MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL LINER, 40MM, +2.5

Model Number 320-40-03

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 06/19/2021

Event Type  Injury  

Event Description

This revision was found during the investigation of (b)(4).Reason for the revision is unknown.

Manufacturer Narrative

Pending evaluation.Concomitant medical products: 320-32-40, 5993404 - expanded glenosphere, 40mm, for small reverse.320-35-01, 6066265 - small glenoid plate.300-01-15, 6113495 - equinoxe, humeral stem primary, press fit 15mm.320-20-34, 6171767 - eq rev compress screw lck cap kit, 4.5 x 34mm.320-10-00, 6203171 - equinoxe reverse tray adapter plate tray +0.320-15-05, 6217400 - eq rev locking screw.320-20-00, 6224120 - eq reverse torque defining screw kit.320-20-30, 6225658 - eq rev compress screw lck cap kit, 4.5 x 30mm.

Manufacturer Narrative

Section h10: (h3) upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is patient conditions.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL LINER, 40MM, +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13634062
• MDR Text Key: 289514335
• Report Number: 1038671-2022-00232
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862535047
• UDI-Public: 10885862535047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2024
• Device Model Number: 320-40-03
• Device Catalogue Number: 320-40-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2019
• 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; Hospitalization
• Patient Sex: Female