MAUDE Adverse Event Report: TORNIER INC. LATITUDE ELBOW PROSTHESIS

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Undesired Nerve Stimulation (1980); Fracture, Arm (2351)

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.Literature reference: elbow hemiarthroplasty for the management of distal humeral fractures: current technique, indications and results.Joideep phadnis, adam c watts, gregory i bain; shoulder & elbow 2016, vol.8(3) 171-183.

Event Description

It was reported in the literature that the following latitude concomitant complications occurred: 4 patients had metalwork removed due to olecranon osteotomy, 2 patient had a periprosthetic fracture, 1 patient had ulnar never irritation requiring subsequent surgery, 6 patients had ulnar never irritation not requiring subsequent surgery, 2 patient had infection (no listed intervention), 20 patient had heteroscopic ossification, 1 patient had heteroscopic ossification with surgical intervention, 1 aseptic loosening requiring revision, 1 lateral collateral reconstruction for posterolateral rotatory instability, and 1 radio-ulnar synostosis.These complications were not reported to be directly related to the latitude prosthesis.No further patient complications have been reported.

• Brand Name: LATITUDE ELBOW PROSTHESIS
• 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: 6125344
• MDR Text Key: 60843514
• Report Number: 3004983210-2016-00051
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K100562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• 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
• Patient Outcome(s): Required Intervention