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

Model Number 400-256

Device Problem Unintended Movement (3026)

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

Event Date 05/16/2014

Event Type  Injury  

Event Description

Star total ankle replacement talar component was exchanged due to talus subsidence.The sliding core mobile bearing was also exchanged.

Manufacturer Narrative

Additional removed components: sliding core mobile bearing.Model # 99-028/12, lot #: 1311182, expiration date: 04/01/2015, device manufacturer date: 03/01/2010.There were no deviations reported in the dhr for part no.99-0028/12, lot no, 1311182 or part no.400-256, lot no.130418/1601.All released parts were within specification.The company's surgery report form states there was no failure involved with the implant 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: 3948928
• MDR Text Key: 4642400
• Report Number: 3003640913-2014-00047
• 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: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: 400-256
• Device Lot Number: 130418/1601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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: 67 YR
• Patient Weight: 84