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

Model Number 400-141, 400-254

Device Problems Degraded (1153); Fracture (1260); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 09/24/2014

Event Type  Injury  

Event Description

Star total ankle replacement sliding core mobile bearing was exchanged due to fractured implant, and talar component was exchanged due to wear.

Manufacturer Narrative

Visual examination of sliding core confirms an asymmetrical wear pattern, which indicates the malalignment of components.The malalignment is most likely the cause of the implant fracture and wear.The dhr for part no.400-141, lot no.0931089 notes that (b)(4) out of (b)(4) pieces were discarded.The dhr for part no.400-254, lot no.091204/0672 notes that (b)(4) out of (b)(4) pieces were discarded.All released parts were within specification.

• Brand Name: STAR TOTAL ANKLE REPLACEMENT
• Type of Device: SLIDING CORE MOBILE BEARING, 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: 4184181
• MDR Text Key: 5094145
• Report Number: 3003640913-2014-00077
• 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: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2015
• Device Model Number: 400-141, 400-254
• Device Lot Number: 0931089, 091204/0672
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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: 54 YR
• Patient Weight: 98