MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TALAR IMPLANT, SIZE 1, RIGHT

Model Number TALAR IMPLANT SZ 1 RT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation is ongoing.The device was not explanted and therefore, not returned for evaluation.

Event Description

A vantage study patient had an ankle replacement surgery where right-sided implants were implanted into his left ankle.This discrepancy was only discovered on (b)(6) 2018 when the clinical research coordinator was filling out the operative crf in the clinical database.The rep ((b)(4)) said the patient is doing well.

Manufacturer Narrative

The implantation of the incorrect devices reported was likely the result of human error.

• Brand Name: VANTAGE
• Type of Device: TALAR IMPLANT, SIZE 1, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 8159459
• MDR Text Key: 130173877
• Report Number: 1038671-2018-00947
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

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: Health Professional
• Device Model Number: TALAR IMPLANT SZ 1 RT
• Device Catalogue Number: 350-02-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/14/2018
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 80