MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 38MM HUMERAL LINER +0

Model Number 320-38-00

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 10/16/2019

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: 320-15-01, 5222680 - eq rev glenoid plate.320-01-38, 5237307 - equinoxe reverse 38mm glenosphere.320-10-00, 5253917 - equinoxe reverse tray adapter plate tray +0.320-20-26, 5280360 - eq rev compress screw lck cap kit, 4.5 x 26mm.320-20-22, 5285155 - eq rev compress screw lck cap kit, 4.5 x 22mm.320-20-26, 5285237 - eq rev compress screw lck cap kit, 4.5 x 26mm.320-20-22, 5288013 - eq rev compress screw lck cap kit, 4.5 x 22mm.320-20-00, 5288766 - eq reverse torque defining screw kit.320-15-05, 5300560 - eq rev locking screw.

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: REVERSE 38MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13634045
• MDR Text Key: 289514604
• Report Number: 1038671-2022-00231
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• 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: 08/14/2022
• Device Model Number: 320-38-00
• Device Catalogue Number: 320-38-00
• 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: 08/15/2017
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female