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

Model Number 400-264

Device Problem Unintended Movement (3026)

Patient Problems Arthritis (1723); No Code Available (3191)

Event Date 02/07/2014

Event Type  Injury  

Event Description

Star total ankle replacement tibial component and sliding core mobile bearing were exchanged due to implant shifting.

Manufacturer Narrative

Add'l remove components: star total ankle replacement, sliding core mobile bearing, model #: 400-142, lot #: 1015116, expiration date: 01/01/2018, date of implantation: (b)(6) 2013, date of explantation: (b)(6) 2014, device manufacture date: 01/2013.There were no deviations reported in the dhr for part no.400-142 lot 1015116.The dhr for part no.400-264, lot 130118/0975 notes that 1 out of the 40 pieces were discarded; all released parts were within specification.The visual evaluation of components confirms only a few marks consistent with removal.

• Brand Name: STAR TOTAL ANKLE REPLACEMENT
• Type of Device: TIBIAL COMPONENT
• 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: 3676829
• MDR Text Key: 19799414
• Report Number: 3003640913-2014-00021
• 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: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: 400-264
• Device Lot Number: 130118/0975
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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: 70 YR