MAUDE Adverse Event Report: ZIMMER INC UNKNOWN INSALL / BURSTEIN TIBIAL COMPONENT; KNEE PROSTHESIS

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It is reported that the patient was revised due to a loose tibial component and polyethylene wear at 15 years post - implant.

Manufacturer Narrative

Information was received via published literature.Please reference literature at the following location: http://jbjs.Org/content/96/18/e159.This report will be amended when our investigation is complete.

• Brand Name: UNKNOWN INSALL / BURSTEIN TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4709798
• MDR Text Key: 5719428
• Report Number: 1822565-2015-00561
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: LOT #UNK; INSALL / BURSTEIN ARTICULAR SURFACE, CATALOG #UNK,
• Patient Outcome(s): Required Intervention