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

Model Number 400-252

Device Problem Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/26/2014

Event Type  Injury  

Event Description

Star total ankle replacement components were removed due to patient's talar fracture and subsided implant.

Manufacturer Narrative

Additional removed components: sliding core mobile bearing.Model#: 99-0028/11.Lot#: 1236065.Expiration date: 10/01/2017.Device manufacture date: 10/2012.Tibial component.Model#: 400-262.Lot#: 100325/0130.Expiration date: 07/01/2015.Device manufacture date: 07/2010.Company report form states there was good osseointegration on the tibial component, but talar component was loose.There were no deviations reported in the dhr for part no.99-0028/11, lot no.1236065.The dhr for part no.400-252 notes that 1 out of 40 pieces were discarded; and for part no.400-262, lot no.100325/0130 notes that 4 out of 40 pieces were discarded.All released parts were within specification.

• Brand Name: STAR TOTAL ANKLE REPLACEMENT
• Type of Device: TALAR 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: 4122394
• MDR Text Key: 4934788
• Report Number: 3003640913-2014-00067
• 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: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: 400-252
• Device Lot Number: 091217/3297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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: 70 YR