MAUDE Adverse Event Report: TORNIER INC. LATITUDE; HUMERAL COMPONENT LARGE RIGHT

Catalog Number DKY003

Device Problem Mechanical Problem (1384)

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

Event Date 03/01/2006

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Chronic triceps rupture, right elbow, status post total.Elbow arthroplasty.Right elbow restore function, decrease pain.

• Brand Name: LATITUDE
• Type of Device: HUMERAL COMPONENT LARGE RIGHT
• 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: 5196718
• MDR Text Key: 30202446
• Report Number: 3004983210-2015-00044
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000003
• 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: DKY003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2014
• 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: ULNAR STEM, STANDARD, LARGE, RIGHT
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR