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

Model Number 400-264

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 12/03/2014

Event Type  Injury  

Event Description

Star total ankle replacement components were removed, and the pt's ankle was revised to fusion.

Manufacturer Narrative

Additional removed components: star total ankle replacement sliding core mobile bearing model#: 99-0028/12, lot#: 1236067, expirations date: 10/01/2017, device manufacture date: 10/2012.Star total ankle replacement talar component, model#: 400-257, lot#: 091204/2557, expiration date: 04/01/2015, device manufacture date: 04/2010.Company report form states pt's ankle was in valgus and the pt did not have deltoid function.There were no deviations reported in the dhrs for part no 99-0028/12, lot no.1236067.The dhr for part no 400-257, lot no.091204/2557 notes that 3 out of 40 pieces were discarded, and 1 was subject to rework.All released parts were within specification.

• Brand Name: STAR TOTAL ANKLE REPLACEMENT
• Type of Device: TIBIAL COMPONENT
• Manufacturer (Section D): SMALL BONE INNOVATIONS, INC.; morrisville PA
• Manufacturer Contact: steve ward ; 1380 s. pennsylvania ave.; morrisville, PA 19067 ; 2153376481
• MDR Report Key: 4364321
• MDR Text Key: 22061459
• Report Number: 3003640913-2014-00097
• 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: 12/01/2014

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: 09/01/2017
• Device Model Number: 400-264
• Device Lot Number: 110602/2526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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: 72 YR