MAUDE Adverse Event Report: TORNIER INC. LATITUDE; ULNAR CAP LARGE

Catalog Number DKY069

Device Problem Mechanical Problem (1384)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 08/04/2011

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Failed latitude articulation right elbow.Removal of loose coupling component of the latitude implant.Inspection of articulation.Reapplication of the latitude locking mechanism.

• Brand Name: LATITUDE
• Type of Device: ULNAR CAP LARGE
• Manufacturer (Section D): TORNIER INC.; 10801 nesbit avenue south; bloomington MN 55437
• Manufacturer Contact: kevin smith ; 10801 nesbit ave south; bloomington, MN 55437 ; 9529217121
• MDR Report Key: 5196720
• MDR Text Key: 30202278
• Report Number: 3004983210-2015-00047
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DKY069
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2015
• 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
• Treatment: ANTERIOR OFFSET SPOOL LARGE RIGHT
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR