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

Model Number 400-263

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Arthritis (1723); Pain (1994); Inadequate Osseointegration (2646)

Event Date 05/21/2014

Event Type  Injury  

Event Description

Star total ankle replacement components were removed due to ankle pain.

Manufacturer Narrative

Additional removed components: sliding core mobile bearing.Model #: 400-142.Lot #: 1018054.Expiration date: 05/01/2017.Device manufacture date: 05/2012.Additional removed components: talar component.Model #: 400-255.Lot #: 100603/5368.Expiration date: 03/01/2018.Device manufacture date: 03/01/2013.There were no deviations reported in the dhrs for part no.400-142, lot no.1018054, part no.400-263 lot no.130304/0091 discarded 1 piece and reworked 1 piece out of a total of 20.The dhr for part no.400-258, lot 100603/5368 notes that 3 pieces were discarded and 7 pieces were reworked out of a total of 40.All released parts were within specification.Visual examination confirms insufficient osseointegration on the talar component.A fair amount of bone growth was evident on the tibial component, but fibrous tissue was also found there.The sliding core mobile bearing shows no signs of excessive wear.

• Brand Name: STAR TOTAL ANKLE REPLACEMENT
• Type of Device: TIBIAL 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: 3948929
• MDR Text Key: 4646065
• Report Number: 3003640913-2014-00050
• 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: 05/29/2014

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: 05/01/2018
• Device Model Number: 400-263
• Device Lot Number: 1300304/0091
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 52 YR
• Patient Weight: 100