MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5

Catalog Number 320-42-13

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

There was a disassociation of the humeral liner from the humeral adaptor tray.Due to the disassociation the original liner and adaptor tray were removed and revised to a new liner and adaptor tray.

Manufacturer Narrative

The revision reported was likely the result of not fully seating the humeral liner in the humeral adapter tray at the time of implantation, which led to humeral liner disassociation.

Manufacturer Narrative

The following sections have updated info : (g4) date received by manufacturer.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8267004
• MDR Text Key: 133724253
• Report Number: 1038671-2019-00002
• 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: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-42-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention