MAUDE Adverse Event Report: TORNIER SALTO TALARIS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 08/01/2008

Event Type  Injury  

Event Description

Tornier made ankle joint replacement hardware.Went through fda trials and was approved.I was told by doctor the clinical tests lasted 13 years, failed after 4, had 2nd one done resulting in two fusions and now possible amputation.Looking for help.

• Brand Name: SALTO TALARIS
• Type of Device: SALTO TALARIS
• Manufacturer (Section D): TORNIER
• MDR Report Key: 5327393
• MDR Text Key: 34418910
• Report Number: MW5058737
• Device Sequence Number: 1
• Product Code: HSN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/21/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 50 YR
• Patient Weight: 76