MAUDE Adverse Event Report: SMALL BONE INNOVATIONS, INC. STAR TOTAL ANKLE REPLACEMENT; SLIDING CORE MOBILE BEARING

Model Number 400-140F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 09/08/2014

Event Type  Injury  

Event Description

Star total ankle replacement system was removed due to patient's wound dehiscence and infection.An antibiotic cement spacer has been placed until infection can be cleared.

Manufacturer Narrative

Additional removed components: tibial component, model#: 400-264, lot#: 130514/1659, expiration date: 08/01/2018, (b)(6) 2014, (b)(6) 2014, device manufacture date: 08/2013; talar component, model#: 400-256, lot#: 100422/0320, expiration date: 07/01/2015, (b)(6) 2014, device manufacture date: 07/2010.The dhr for part no.400-264, lot no.130514/1659 notes that 2 out of 40 pieces were discarded.The dhrs for both part no.400-140f, lot 1415286, and part no.400-256, lot no.100422/0320 show no deviations.All released parts were within specification.

• Brand Name: STAR TOTAL ANKLE REPLACEMENT
• Type of Device: SLIDING CORE MOBILE BEARING
• Manufacturer (Section D): SMALL BONE INNOVATIONS, INC.; morrisville PA
• Manufacturer Contact: steve ward ; 1380 s. pennsylvania ave.; morrisville, PA 19067 ; 2153376481
• MDR Report Key: 4122393
• MDR Text Key: 4920254
• Report Number: 3003640913-2014-00070
• 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: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: 400-140F
• Device Lot Number: 1415286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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: 64 YR