MAUDE Adverse Event Report: TORNIER INC. LATITUDE ELBOW PROSTHESIS

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

Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.Literature reference: total elbow arthroplasty following complex fractures of the distal humerus: results in patients over 65 years of age.Francesco pogliacomi, paolo schiavi, massimo defilippo, filippo calderazzi, maurizio corradi, enrico vaienti, francesco ceccarelli, roberto rotini.Acta biomed 2016; vol.87, n.2: 148-155.

Event Description

It was reported in the literature that the latitude device was concomitant but did not cause or contribute to the following complications requiring intervention: 2 superficial wound infection: iv antibiotic treatment and secondary wound debridement and 1 deep early infection (staphylococcus aureus).Antibiotics, wound cleaning needed.No further patient complications have been reported for this event.

• 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: 6125359
• MDR Text Key: 60808694
• Report Number: 3004983210-2016-00052
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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