MAUDE Adverse Event Report: TORNIER S.A.S. SALTO TALARIS TIBIAL INSERT LEFT SIZE 1

Model Number THICKNESS 8 MM

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 07/02/2015

Event Type  Injury  

Event Description

Patient has infection after total ankle arthroplasty performed on (b)(6) 2015.Surgeon performed i and d and removed salto talaris tibial insert as a precaution.

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.

Manufacturer Narrative

Medical device is manufactured in accordance with our specifications.Root cause of reported event could not be confirmed.Known inherent risk of procedure, the link with the concerned device is highly improbable this is the final report submitted regarding this surgical event and medical device.The not returned to manufacturer.

Event Description

Patient has infection after total ankle arthroplasty performed on (b)(6) 2015.Surgeon performed i&d and removed salto talaris tibial insert as a precaution.

• Brand Name: SALTO TALARIS TIBIAL INSERT LEFT SIZE 1
• Type of Device: SALTO TALARIS TIBIAL INSERT LEFT SIZE 1
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: segolene pollet ; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330 ; 76613500
• MDR Report Key: 4945043
• MDR Text Key: 6635308
• Report Number: 3000931034-2015-00127
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: THICKNESS 8 MM
• Device Catalogue Number: LJU245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR