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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN CR-FLEX GSF FEMORAL COMPONENT

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ZIMMER, INC. NEXGEN CR-FLEX GSF FEMORAL COMPONENT Back to Search Results
Catalog Number 00575201502
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Fall (1848); Pain (1994)
Event Date 02/25/2015
Event Type  Injury  
Event Description

It is reported that the pt was revised due to pain and loosening of the femoral and tibial components. The pt fell 3 months prior to the revision.

 
Manufacturer Narrative

Info was received from a foreign source who is not required to complete form 3500a. This report will be amended when our investigation is complete.

 
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Brand NameNEXGEN CR-FLEX GSF FEMORAL COMPONENT
Manufacturer (Section D)
ZIMMER, INC.
p.o. box 708
warsaw IN 46580 070
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw, IN 46580-0708
8006136131
MDR Report Key4647933
MDR Text Key5602573
Report Number1822565-2015-00439
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
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 02/25/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2018
Device Catalogue Number00575201502
Device LOT Number60976948
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/25/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2008
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: 03/31/2015 Patient Sequence Number: 1
Treatment
CAT#00593004002, LOT#60953930,; NEXGEN CRR-FLEX MOBILE BEARING TIBIAL COMPONENT,
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