MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

Catalog Number 320-10-00

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Revision due to patient fall.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of nerve irritation due to the positioning and/or length of one of the compression screws used to secure the glenoid plate.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of the patient's fall, which led to loosening of the humeral stem and fracture of the greater and lesser tuberosities.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8147550
• MDR Text Key: 129820135
• Report Number: 1038671-2018-00937
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention