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

Model Number 400-262

Device Problems Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/06/2014

Event Type  Injury  

Event Description

Star total ankle replacement components were removed due to implant loosening most likely caused by inadequate osteointegration.The lack of osteointegration is believed to be attributed to a non-compliant patient.

Manufacturer Narrative

Additional removed components: star total ankle replacement, sliding core mobile bearing, model#: 400-140; lot#: 0928123; expiration date: 01/01/2015, device manufacture date: 01/2010.Star total ankle replacement, talar component,model#: 400-252, lot#: 091204/2359; expiration date: 06/01/2015; device manufacturer date: 06/2010.There were no deviations reported in the dhrs for part no.400-140, lot no.0928123; and part no.400-252, lot no.091204/2359.The dhr for part no.400-262, lot no.100311/2966 notes that 2 outof 40 pieces were discarded.All released parts were within specification.

• Brand Name: STAT 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: 4218731
• MDR Text Key: 4976102
• Report Number: 3003640913-2014-00081
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2014

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: Other
• Device Expiration Date: 07/01/2015
• Device Model Number: 400-262
• Device Lot Number: 100311/2966
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR