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

Model Number 400-263

Device Problem Use of Device Problem (1670)

Patient Problems Arthritis (1723); Bone Fracture(s) (1870); Pain (1994)

Event Date 12/10/2013

Event Type  Injury  

Event Description

Patient had star tibial component and sliding core mobile bearing revised.

Manufacturer Narrative

Patient had a re-operation to address lateral pain.Company report form indicates that the surgeon replaced the tibial component adjusting the location of placement, and exchanged the sliding core mobile bearing.The dhr for part no.400-141, lot 1010032 shows no anomalies; the dhr for part no.400-263, lot 110602/2566 noted that (b)(4) pieces were discarded, and (b)(4) were re-worked; 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: james o'connor ; 1380 s. pennsylvania ave.; morrisville, PA 19067 ; 2153376354
• MDR Report Key: 3591465
• MDR Text Key: 4035958
• Report Number: 3003640913-2014-00001
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• 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: 400-263
• Device Lot Number: 110602/2566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2013
• 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
• Treatment: STAR TOTAL ANKLE REPLACEMENT; EXPLANT:; MODEL#: 400-141, LOT#: 1010032, MFR DATE 12/2011; IMPLANT:; SLIDING CORE MOBILE BEARING
• Patient Age: 61 YR
• Patient Weight: 95