MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 42MM HUMERAL LINER +0

Catalog Number 320-42-00

Device Problem Unstable (1667)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2017.Revision due to instability.

Manufacturer Narrative

The revision reported was likely the result of instability.However, this cannot be confirmed as the devices were not returned an no further information was provided.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 42MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8226134
• MDR Text Key: 132414719
• Report Number: 1038671-2019-00999
• 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
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention