MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE CAGE GLENOID S, POST AUG, LEFT

Catalog Number 314-13-22

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

The glenoid center cage and one of the peripheral pegs sheared off of the poly.

Manufacturer Narrative

The revision reported was likely the result of drilling the central cage hole at an angle relative to the peripheral peg holes, which created a bending moment on the central cage causing the central peg to fail and the polyethylene articular surface to disassociate as reported.The differing central and peripheral peg drill axes in this patient were likely influenced by the severity of posterior glenoid wear, which required eccentric reaming of the glenoid.

Manufacturer Narrative

The following sections have additional/updated info : (g4) date received by manufacturer: 05-dec-2018.(d6) if implanted, give date: (b)(6) 2015.

Manufacturer Narrative

The following sections have updated info: (d4) serial number, expiration date.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE CAGE GLENOID S, POST AUG, LEFT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8179199
• MDR Text Key: 130871466
• Report Number: 1038671-2018-00974
• 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,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2020
• Device Catalogue Number: 314-13-22
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 69