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

Model Number 400-144

Device Problem Degraded (1153)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 09/08/2014

Event Type  Injury  

Event Description

Star total ankle replacement system was removed and revised to fusion.The sliding core mobile bearing is degraded following the patient's fracture of the medical malleolus.

Manufacturer Narrative

Additional removed components: tibial component, model#: 400-263, lot#: 100204/2634, expiration date: 03/01/2015.Device manufacture date: 03/2010.Talar component, model#: 400-257, lot#: 091204/2541, expiration date: 04/01/2015, device manufacture date: 04/2010.Visual examination confirms that the degradation of the sliding core mobile bearing is consistent with an unstable ankle.The dhr for part no.400-144, lot no.0940060 shows no deviations.The dhr for part no.400-263, lot 100204/2634 notes that (b)(4) were subject to rework; and the dhr for part no.400-257, lot no.091204/2541 notes that (b)(4) pieces were subject to rework, and 3 pieces were discarded.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: 4122391
• MDR Text Key: 4920253
• Report Number: 3003640913-2014-00069
• 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: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• 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: 400-144
• Device Lot Number: 0940060
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 74 YR
• Patient Weight: 90