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

Model Number 400-258

Device Problems Patient-Device Incompatibility (2682); Unintended Movement (3026)

Patient Problem Inadequate Osseointegration (2646)

Event Date 05/15/2014

Event Type  Injury  

Event Description

Star total ankle replacement system were revised to fusion due to malalignment and talar subsidence caused by poor bone quality beneath the talar component.

Manufacturer Narrative

Additional removed components: sliding core mobile bearing, model #400-141, lot: 0921074, exp date: 03/01/2015.Device mfr date: 03/01/2010.Additional removed components: tibial component, model # 400-264, lot# 090807/1951, exp date: 10/01/2014, device mfr date: 10/01/2009.There were no deviations reported in the dhrs for part no.400-141, lot no.0921074.The dhr for part no.400-258, lot no.090319/2607 notes that 5 out of the 30 pieces were scrapped, and part no.400-264, lot no.090807/1951 notes that 5 out of 30 pieces were also scrapped.All released parts were within specification.The talar and tibial components were not returned, only the sliding core mobile bearing is available.Visual examination of the slider core confirms wear marks consistent with the malalignment of components.

• Brand Name: STAR TOTAL ANKLE REPLACEMENT
• Type of Device: TALAR COMPONENT
• Manufacturer (Section D): SMALL BONE INNOVATIONS, INC.; morrisville PA
• Manufacturer Contact: kevin ladd ; 1380 s. pennsylvania ave.; morrisville, PA 19067 ; 2153376436
• MDR Report Key: 4004667
• MDR Text Key: 15108475
• Report Number: 3003640913-2014-00054
• 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: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: 400-258
• Device Lot Number: 090319/2607
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• 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: 61 YR