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

Model Number 400-262

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 01/27/2014

Event Type  Injury  

Event Description

Star total ankle replacement was revised to correct loosening of tibial component.All three components were removed on (b)(6) 2014 due to infection.An antibiotic spacer was placed, and components will be replaced at a later date.

Manufacturer Narrative

Additional removed components: star total ankle replacement, sliding core mobile bearing, model #: 400-142, lot #: 1250135, expiration date: 01/01/2018, date if implantation: (b)(6) 2013, date of explantation: (b)(6) 2014, device manufacturer date: 01/2013.Star total ankle replacement, talar component, model #: 400-253, lot #: 091217/3763, expiration date: 07/01/2015, date of implantation: (b)(6) 2013, date of explantation: (b)(6) 2014, device manufacture date: 07/2010.There were no deviations reported in the dhrs for all the parts.Visual examination confirms marks on all three components are 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: 3677169
• MDR Text Key: 15123668
• Report Number: 3003640913-2014-00014
• 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: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• 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: 400-262
• Device Lot Number: 100211/2053
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2014
• 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: 43 YR