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U.S. Department of Health and Human Services

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

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ZIMMER, INC NEXGEN TM TIBIAL COMPONENT MBH Back to Search Results
Catalog Number 00595403702
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Date 01/16/2015
Event Type  Injury  
Event Description

It was reported that the patient was revised due to loosening of the tibia component.

 
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
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Brand NameNEXGEN TM TIBIAL COMPONENT
Type of DeviceMBH
Manufacturer (Section D)
ZIMMER, INC
po box 708
warsaw IN 46581 070
Manufacturer Contact
kevin escapule
po box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key4683724
MDR Text Key5640753
Report Number1822565-2015-00508
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00595403702
Device LOT Number62569193
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/09/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/09/2015 Patient Sequence Number: 1
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