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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC NEXGEN CR-FLEX POROUS FEMORAL COMPONENT MBH

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ZIMMER INC NEXGEN CR-FLEX POROUS FEMORAL COMPONENT MBH Back to Search Results
Catalog Number 00595201601
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 07/13/2015
Event Type  Injury  
Manufacturer Narrative

Information was received from a consumer who is not required to complete form 3500a. (b)(4). This report will be amended when our investigation is complete.

 
Event Description

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

 
Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed. The device history records for the device were reviewed and identified no deviations or anomalies. Review of the compatibility matrix identified that all the components are compatible. This device is used for treatment. A complaint history search identified no other complaint for the part/lot combination of the femoral component. The primary surgical notes state that the patient complained of severe pain in the left knee and radiographic imaging found minimal osteoarthritis. After resecting the femur and tibia, provisional components were put in place and led to satisfying flexion/extension and varus/valgus stability as well as alignment. After cleaning and press fitting the femoral, tibial and patellar components, there was good patellar tracking without any subluxation. The revision surgical notes state that the patient experienced pain and it was difficult to identify the source of pain. The patellar component was revised a year or two before the total revision. No infection was identified but there was suspicion of femoral loosening. Intra-operatively, osteotomes were used to undercut the femoral component which was easily disimpacted. The tibial component was also removed. The patient is described to be a healthy and active individual. Per the package insert of the femoral component, loosening or fracture/damage of the prosthetic knee components or surrounding tissues, as well as pain are known adverse effects of the tka procedure. The insert also mentions that complications and/or failure of total knee prostheses are more likely in patients with unrealistic functional expectations, physically active patients, and/or with patients that fail to follow through with the required rehabilitation program. No product issue were identified and a definitive root cause cannot be determined with the information provided.

 
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Brand NameNEXGEN CR-FLEX POROUS 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 Key5419712
MDR Text Key37783550
Report Number1822565-2016-00235
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2017
Device Catalogue Number00595201601
Device LOT Number60826834
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 Received07/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/09/2007
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: 02/09/2016 Patient Sequence Number: 1
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