MAUDE Adverse Event Report: TORNIER S.A.S. SALTO TALARIS ANKLE PROSTHESIS

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Test Result (2695)

Event Type  Injury  

Manufacturer Narrative

Analysis of an article "short to midterm clinical and radiographic outcomes of the salto total ankle prosthesis" scott r.Nodzo, michael p.Miladore, nathan b.Kaplan and christopher a.Ritter foot ankle int 2014 35: 22 originally published online 24 october 2013.This is the final report submitted regarding this surgical event and medical device.

Event Description

One patient who required a revision taa due to pain and progressive radiolucencies around the components 3 years after the index procedure.

• Brand Name: SALTO TALARIS ANKLE PROSTHESIS
• Type of Device: SALTO TALARIS ANKLE PROSTHESIS
• 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: 5242731
• MDR Text Key: 31827479
• Report Number: 3000931034-2015-00188
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other