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

Model Number 400-263

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Arthritis (1723); Pain (1994)

Event Date 05/08/2014

Event Type  Injury  

Event Description

Star total ankle replacement was revised due to patient experiencing medial pain.Tibial component was replaced to address base plate loosening, and sliding core mobile bearing was also exchanged.

Manufacturer Narrative

Additional removed components: common device name: sliding core mobile bearing, model #: 400-140, lot #: 1306010, expiration date: 12/01/2015.Device manufacture date: 12/01/2010.There are no deviations reported in the dhr for part no.400-140, lot 1306010.The dhr for part no.400-263, lot 100325/0166.Note that 2 out of 40 pieces were discarded and 10 pieces were subject to re-work; 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: kevin ladd ; 1380 s. pennsylvania avenue; morrisville, PA 19067 ; 2153376436
• MDR Report Key: 3874020
• MDR Text Key: 4508758
• Report Number: 3003640913-2014-00040
• 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: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Model Number: 400-263
• Device Lot Number: 100325/0166
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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: 55 YR
• Patient Weight: 54