MAUDE Adverse Event Report: TORNIER INC. LATITUDE ELBOW PROSTHESIS HUMERAL STEM COATED, SMALL, RIGHT, 72MM

Catalog Number 0030302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 07/28/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the implanted latitude was removed from the patient's right shoulder due to infection.A new device was placed.No further patient complications have been reported.

Event Description

It was reported that the implanted latitude was removed from the patient's right elbow due to infection.A new device was placed.No further patient complications have been reported.

• Brand Name: LATITUDE ELBOW PROSTHESIS HUMERAL STEM COATED, SMALL, RIGHT, 72MM
• Type of Device: ELBOW PROSTHESIS
• Manufacturer (Section D): TORNIER INC.; 10801 nesbit avenue south; bloomington MN 55437
• Manufacturer Contact: dustin smith ; 10801 nesbit ave south; bloomington, MN 55437 ; 9529217121
• MDR Report Key: 5864942
• MDR Text Key: 51735493
• Report Number: 3004983210-2016-00032
• Device Sequence Number: 1
• Product Code: JDC
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 0030302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/19/2016
• 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: RADIAL HEAD, SMALL
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR