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U.S. Department of Health and Human Services

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

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ZIMMER, INC. NEXGEN TM TIBIAL COMPONENT Back to Search Results
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.

 
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Brand NameNEXGEN 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 Key4660231
MDR Text Key16859917
Report Number1822565-2015-00464
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received04/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00595404701
Device LOT Number61711851
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received03/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2011
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
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