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

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Had an ankle replacement with salto talaris in (b)(6) in 2010.Now live in for(b)(6).It has failed and i need a revision.Local surgeon's office seem to be having trouble locating a rep.Would like to proceed with surgery asap.Please call me with the information that i can give to (b)(6), md of joint implant surgeon of (b)(6).Revision surgery for changing pe insert done in (b)(6) 2015.

Manufacturer Narrative

Root cause of reported event could not be confirmed.This is the final report submitted regarding this surgical event and medical device.

Event Description

Had an ankle replacement with (b)(6) in 2010.Now live in (b)(6).It has failed and i need a revision.Local surgeon's office seem to be having trouble locating a rep.Would like to proceed with surgery asap.Please call me with the information that i can give to (b)(6), md of joint implant surgeon of (b)(6).Revision surgery for changing pe insert done in (b)(6) 2015.

• Brand Name: SALTO TALARIS ANKLE PROSTHESIS
• Type of Device: INSERT PE
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer (Section G): TORNIER SAS; 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: 5088275
• MDR Text Key: 26191313
• Report Number: 3000931034-2015-00138
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Followup
• Report Date: 08/21/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2016
• 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