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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NATURAL KNEE FLEX FEMORAL COMPONENT MBH

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ZIMMER, INC. NATURAL KNEE FLEX FEMORAL COMPONENT MBH Back to Search Results
Catalog Number 00541201601
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Date 09/22/2014
Event Type  Injury  
Event Description

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

 
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Manufacturer Narrative

Device history records were reviewed and no deviations or anomalies were found. This device is used for treatment. Primary surgery notes were not provided. It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. Review of the revision operative notes confirms that the patient underwent a left revision total knee arthroplasty due to a loose femoral component. An abundant amount of synovitis was removed. The surgeon stated that the "femoral component appears to be fairly welded to the distal femur". Some fibrous material surrounding the edges of the femoral component was found and the femoral component was explanted using a series of osteotomes and extractor. Minimal bone loss was noted. The package insert states that loosening is an adverse effect. This is therefore a known inherent risk of the procedure. A product history search revealed no additional complaints against the related part and lot combinations. A definitive root cause cannot be determined with the information provided.

 
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Brand NameNATURAL KNEE FLEX FEMORAL COMPONENT
Type of DeviceMBH
Manufacturer (Section D)
ZIMMER, INC.
p.o. box 708
warsaw IN 46581 0708
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key4944993
MDR Text Key20805067
Report Number1822565-2015-01316
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,DISTRIBUTOR,HEALTH PROF
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/25/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2018
Device Catalogue Number00541201601
Device LOT Number61103111
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/22/2008
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: 07/24/2015 Patient Sequence Number: 1
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