MAUDE Adverse Event Report: TORNIER INC. LATITUDE RADIAL HEAD; NONE

Catalog Number DKY059

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2014

Event Type  malfunction  

Event Description

During a revision surgery on (b)(6) 2014 the radial head is removable from the stem without using any force.The surgery was to place a cap to constrain the latitude.During surgery the radial head prosthese was visibly not fixed in cement.During removal of the radial part of the prosthese the head just came off the stem.

Manufacturer Narrative

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

• Brand Name: LATITUDE RADIAL HEAD
• Type of Device: NONE
• Manufacturer (Section D): TORNIER INC.; bloomington MN
• Manufacturer (Section G): TORNIER INC.; 10801 nesbitt ave south; bloomington MN 55437
• Manufacturer Contact: kevin smith ; 10801 nesbitt ave south; bloomington, MN 55437 ; 9524267643
• MDR Report Key: 4037125
• MDR Text Key: 4724520
• Report Number: 3004983210-2014-00016
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• PMA/PMN Number: K100562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DKY059
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2014
• 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