MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CON ART INS 9MM SZ 5-6; KNEE IMPLANT

Catalog Number 71420537

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 10/03/2014

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to disassociation.

• Brand Name: LEGION CON ART INS 9MM SZ 5-6
• Type of Device: KNEE IMPLANT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: connie mcbroom ; 1450 brooks road; memphis, TN 38116 ; 9013995985
• MDR Report Key: 4140784
• MDR Text Key: 4933622
• Report Number: 1020279-2014-00613
• Device Sequence Number: 1
• Product Code: HSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 71420537
• Device Lot Number: 12BM78894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/26/2014
• Date Manufacturer Received: 09/26/2014
• Date Device Manufactured: 02/01/2012
• 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