MAUDE Adverse Event Report: TORNIER INC. LATITUDE ELBOW PROSTHESIS, RADIAL HEAD, MEDIUM

Catalog Number DKY057

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 06/08/2018

Event Type  malfunction  

Event Description

It was reported that the patient underwent a revision due to the screw of the humeral anatomic stem was wobbly and therefore caused loosening of the spool.Side-effect was an inflammatory pseudo tumor in the joint. when the surgeon tried to open the ulnar cap, he found pieces of the apparently beforehand broken ulnar cap tab in the joint. .

• Brand Name: LATITUDE ELBOW PROSTHESIS, RADIAL HEAD, MEDIUM
• 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: 7671252
• MDR Text Key: 113511291
• Report Number: 3004983210-2018-00025
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DKY057
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2018
• 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
• Patient Outcome(s): Required Intervention