MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, GLENOID, CAGE PEGGED, BETA

Catalog Number 314-13-14

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Joint Disorder (2373)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2017.Revision due to subscapularis tear.The case report form indicates these events are definitely not related to devices and procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Rotator cuff strains or tears are caused by overuse or acute injury.Revisions or surgical interventions are a known complication found in joint replacements.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of rotator cuff and the subsequent revision, it is most likely related to the patient's underlying conditions.This device is used for treatment, not diagnosis.No evaluation pending.

Event Description

This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00504, 1038671-2018-00505, 1038671-2018-00506 and 1038671-2018-00507.

• Brand Name: EQUINOXE, GLENOID, CAGE PEGGED, BETA
• Type of Device: GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7609105
• MDR Text Key: 111305615
• Report Number: 1038671-2018-00507
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 314-13-14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 75