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

Model Number NOT REPORTED

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a failure of bone ingrowth into the component.

Manufacturer Narrative

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

• Brand Name: SALTO TALARIS PROSTHESIS
• Type of Device: ANKLE PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo-sanchez ; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330 ; 76613500
• MDR Report Key: 6140594
• MDR Text Key: 61290937
• Report Number: 3000931034-2016-00213
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2016
• 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