MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; FLUTED STEM EXTENSION 40L X 14 MM

Catalog Number 204-34-04

Device Problem Microbial Contamination of Device (2303)

Patient Problems Sepsis (2067); No Code Available (3191)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2015.Revision due to sepsis of a total knee arthroplasty.The case report form indicates this event is possibly related to devices and procedure.

Manufacturer Narrative

This event report was received through clinical data collection activities.Engineering evaluation noted that the revision reported was likely the result of infection, which is addressed in the product labeling under general surgical risks.

• Brand Name: OPTETRAK
• Type of Device: FLUTED STEM EXTENSION 40L X 14 MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8206095
• MDR Text Key: 131709924
• Report Number: 1038671-2018-00981
• Device Sequence Number: 1
• Product Code: JWH
• 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: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 204-34-04
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/02/2018
• Date Manufacturer Received: 12/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR