MAUDE Adverse Event Report: SMALL BONE INNOVATIONS, INC STAR TOTAL ANKLE REPLACEMENT; SLIDING CORE MOBILE BEARING

Device Problems Material Integrity Problem (2978); Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 10/01/2013

Event Type  Injury  

Event Description

Star total ankle replacement sliding core mobile bearing was exchanged due to wear of implant.

Manufacturer Narrative

The company's surgery report form notes that wear was caused by ankle mal-alignment due to a distal tibia fracture.

• Brand Name: STAR TOTAL ANKLE REPLACEMENT
• Type of Device: SLIDING CORE MOBILE BEARING
• Manufacturer (Section D): SMALL BONE INNOVATIONS, INC; morrisville PA
• Manufacturer Contact: james o'connor ; 1380 s. pennsylvania ave; morrisville, PA 19067 ; 2153376354
• MDR Report Key: 3670266
• MDR Text Key: 15267607
• Report Number: 3003640913-2014-00007
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2013
• 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: PT HAD THEIR DISTAL TIBIA PLATED DUE TO A FRACTURE; DATE UNK.
• Patient Outcome(s): Required Intervention