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

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Between 2006 and 2008 a total of 19 men and 50 women underwent tea (total elbow arthroplasty) surgery.2 (3%) of the patients experienced instability.About three years post-operatively an ulnar cap was introduced to link the components, resulting in decreased pain scores and improved satisfaction.The stability approved in only one elbow.Article citation: bone joint j 2015; 97-b:681-8.According to dr.(b)(6) the results of this article are only based on the latitude system and not latitude ev.Dr.(b)(6) stated that all cases were asymptomatic and no cases were revised because of the rh.

Manufacturer Narrative

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

• Brand Name: LATITUDE TOTAL ELBOW SYSTEM
• 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: 5015756
• MDR Text Key: 25507428
• Report Number: 3004983210-2015-00031
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• PMA/PMN Number: K100562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• 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: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention