MAUDE Adverse Event Report: TORNIER INC. LATITUDE ELBOW PROSTHESIS, HUMERAL SPOOL, MEDIUM, LEFT

Catalog Number DKY214

Device Problem Material Integrity Problem (2978)

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

Event Date 04/20/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent a revision to address metallosis and loose humeral spool and ulnar stem.

• Brand Name: LATITUDE ELBOW PROSTHESIS, HUMERAL SPOOL, MEDIUM, LEFT
• Type of Device: ELBOW PROSTHESIS
• Manufacturer (Section D): TORNIER INC.; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: matt kennedy ; 10801 nesbitt ave s; bloomington, MN 55437 ; 9526837482
• MDR Report Key: 8574843
• MDR Text Key: 143875832
• Report Number: 3004983210-2019-00016
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DKY214
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2019
• 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, MEDIUM, LEFT
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR