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

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

Event Description

Between 2006 and 2008 a total of 19 men and 50 women underwent tea (total elbow arthroplasty) surgery.13 (31%) of the patients experienced disengagement of the radial head component with a radial head component implanted.Article citation: bone joint j 2015; 97-b:681-8.Radial head (rh) disengagement may be due to the surgical technique with a high placement.The rh may have been implanted too high as there is no guide in the latitude legacy instrument set; thus, the surgeon, dr.(b)(6) believes that there is a possibility of over stuffing and thus leading to the dislocation of the head and the stem.According to dr.De vos 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.Only one rh case was revised, but only to link the prosthesis, there was no relation to 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: 5015225
• MDR Text Key: 24594385
• Report Number: 3004983210-2015-00016
• 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