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

Model Number 400-263

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Arthritis (1723); Arthralgia (2355)

Event Date 11/17/2014

Event Type  Injury  

Event Description

Star total ankle replacement components were removed to address loosening of talar and tibial components and correct sizing issues.Sliding core mobile bearing was also exchanged.

Manufacturer Narrative

Additional removed components: tibial component, model#: 400-255, lot#: 090319/2973.Expiration date: 12/01/2014, device manufacture date: 12/2009.Sliding core mobile bearing, model #:400-140, lot#: 0924012, expiration date: 11/2014, device manufacture date: 11/2009.The dhr for part no.400-263, lot no.090528/3322 notes that (b)(4).The dhr for part no.400-255, lot no.090319/2973 notes (b)(4) and the dhr for part no.400-140, lot no.0924012.All released parts were within specification.

• Brand Name: STAR TOTAL ANKEL REPLACEMENT
• Type of Device: TIBIAL COMPONENT
• Manufacturer (Section D): SMALL BONE INNOVATIONS, INC.; morrisville PA
• MDR Report Key: 4316549
• MDR Text Key: 5251771
• Report Number: 3003640913-2014-00090
• 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: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: 400-263
• Device Lot Number: 090528/3322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• 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: 55 YR