MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FB SZ 3 LT 10MM

Catalog Number 350-21-43

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

Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Sepsis (2067); Tachycardia (2095)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Revision due to infection.Patient had a slow-healing wound on left anterior ankle that progressed to a deep infection in the ankle joint.On (b)(6) 2018, the vantage implant was removed, and an antibiotic spacer was placed.The case report form indicates this event is definitely not related to devices and definitely related to procedure.On (b)(6)2018, patient came in with sepsis with fever, tachycardia, rigors, leukocytosis, and relative hypotension.The case report form indicates this event is definitely not related to devices and definitely related to procedure.On (b)(6) 2018, patient was seen again and was weaning out of cam boot and compression stocking; continuing on oral antibiotics daily.The case report form indicates this event is definitely not related to devices and definitely related to procedure.

Manufacturer Narrative

The revision reported was likely the result of infection related to a "slow-healing wound" near the ankle.

• Brand Name: TIBIAL INSERT FB SZ 3 LT 10MM
• Type of Device: TIBIAL INSERT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 8086060
• MDR Text Key: 127850320
• Report Number: 1038671-2018-00891
• Device Sequence Number: 1
• Product Code: HSN
• 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: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 350-21-43
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 117