MAUDE Adverse Event Report: SMALL BONE INNOVATIONS, INC. STAR TOTAL ANKLE REPLACEMENT

Model Number 400-252

Device Problems Failure to Osseointegrate (1863); Improper or Incorrect Procedure or Method (2017)

Patient Problems Arthritis (1723); Inadequate Osseointegration (2646)

Event Date 10/14/2014

Event Type  Injury  

Event Description

Star total ankle replacement talar component was exchanged to correct initial lateral talar cuts.Original surgeon did not clear lateral cut shelf allowing for the appropriate seating between component and bone.The sliding core mobile bearing was also exchanged.

Manufacturer Narrative

Additional removed components: sliding core mobile bearing; model#: 400-140; lot#: 1017090; expiration date: 11/01/2015; device manufacture date: 11/2010.Visual examination of explanted components confirm lack of osseointegration to the talar component and in significant wear to both components.There were no deviations reported in the dhrs either part no.(b)(4), lot no.091204/2311, or part no.(b)(4), lot no.1017090.All released parts were within specification.

• Brand Name: STAR TOTAL ANKLE REPLACEMENT
• Manufacturer (Section D): SMALL BONE INNOVATIONS, INC.; morrisville PA 19067
• Manufacturer Contact: steve ward ; 1380 s. pennsylvania ave.; morrisville, PA 19067 ; 2153376481
• MDR Report Key: 4218712
• MDR Text Key: 18932510
• Report Number: 3003640913-2014-00085
• 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: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Model Number: 400-252
• Device Lot Number: 091204/23/25
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2010
• 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
• Patient Age: 65 YR