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

Model Number 400-41

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Arthralgia (2355)

Event Date 12/08/2014

Event Type  Injury  

Event Description

Star total ankle replacement sliding core mobile bearing was exchanged due to implant fracture.

Manufacturer Narrative

There were no deviations reported in the dhr for part no.400-141, lot no.0939101.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: 4364357
• MDR Text Key: 21727077
• Report Number: 3003640913-2014-00098
• 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: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: 400-41
• Device Lot Number: 0939101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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: 67 YR
• Patient Weight: 118