MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT FIXED BEARING, SIZE 3, RIGHT, 6MM

Catalog Number 350-22-03

Device Problems Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2017.Revision due to infection.The vantage implant was removed and an antibiotic spacer was placed.This event report was received through clinical data collection activities.

Event Description

Patient developed a deep infection in his ankle approximately four (4) weeks postoperatively.On (b)(6) 2017, the vantage implant was removed, and an antibiotic spacer was placed.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00491, 1038671-2018-00492 and 1038671-2018-00493.

Manufacturer Narrative

This device is used for treatment not diagnosis.

• Brand Name: TIBIAL INSERT FIXED BEARING, SIZE 3, RIGHT, 6MM
• Type of Device: TIBIAL INSERT FIXED BEARING, SIZE 3, RIGHT, 6MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7591116
• MDR Text Key: 110747753
• Report Number: 1038671-2018-00492
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K152217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

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: Physician
• Device Catalogue Number: 350-22-03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 01/03/2019
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 82