MAUDE Adverse Event Report: TORNIER, INC LATITUDE TOTAL ELBOW PROSTHESIS

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Fifty-eight patients underwent latitude total elbow replacement.Of the 58 patients 6 patients required revision surgery.Two of the 6 revisions were due to aseptic loosening.Article: early results of latitude primary total elbow replacement with a minimum follow up of two years, authors: saurabh mehta, ann birch, prof a watts, prof ian trail.

Manufacturer Narrative

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

• Brand Name: LATITUDE TOTAL ELBOW PROSTHESIS
• Type of Device: ELBOW PROSTHESIS
• Manufacturer (Section D): TORNIER, INC; 10801 nesbitt ave south; bloomington MN 55437
• Manufacturer (Section G): TORNIER, INC.; 10801 nesbitt ave south; bloomington MN 55437
• Manufacturer Contact: kevin smith ; 10801 nesbitt ave south; bloomington, MN 55437 ; 9529217121
• MDR Report Key: 5065134
• MDR Text Key: 25312279
• Report Number: 3004983210-2015-00032
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2015
• 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