MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN TM TIBIAL COMPONENT

Catalog Number 00595404701

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 02/26/2015

Event Type  Injury  

Event Description

It is reported that the patient was revised due to loosening and pain.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: NEXGEN TM TIBIAL COMPONENT
• 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: 4660231
• MDR Text Key: 16859917
• Report Number: 1822565-2015-00464
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/02/2015

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/02/2015
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 00595404701
• Device LOT Number: 61711851
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 02/01/2011
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data

Patient TREATMENT DATA

Date Received: 04/02/2015 Patient Sequence Number: 1