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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN FEMORAL COMPONENT POROUS RIGHT SIZE F PROSTHESIS, KNEE

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ZIMMER, INC. NEXGEN FEMORAL COMPONENT POROUS RIGHT SIZE F PROSTHESIS, KNEE Back to Search Results
Catalog Number 00595201602
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Pain (1994)
Event Date 01/30/2014
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant products: nexgen porous stemmed tibial plate size 6, item # 00598204702, lot # 54071300. Nexgen articular surface size green/c-h 14mm, item # 90597004014, lot # 56268800. Nexgen all poly patella size 35mm, item # 00597206535, lot # 60107540. Self-tapping bone screw 6. 5mm, item # 00511007030, lot # 25005800. Self-tapping bone screw 6. 5mm, item # 00511007040, lot # 20132000. Self-tapping bone screw 6. 5mm, item # 00511007040, lot # 20131900. Self-tapping bone screw 6. 5mm, item # 00511007040, lot # 21093200. Customer has indicated that the product will not be returned to zimmer biomet for investigation due to the location of the device is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-04597, 0001822565-2017-04598, 0002648920-2017-00433, 0002648920-2017-00434, 0002648920-2017-00435, 0002648920-2017-00436, 0002648920-2017-00437.

 
Event Description

It was reported following an initial knee arthroplasty, the patient was revised due to loosening. The patient was experiencing pain. No additional patient consequences were reported.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. The following sections were updated: reported event was confirmed by review of op notes. Device history record was reviewed and no discrepancies relevant to the reported event were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

Revision operation notes state that patient was revised on right knee due to pain, aseptic loosening of the knee components and possible infection. It was noted that the bone behind the femur was quite soft and femoral component appeared to be loose and came off quite easily. The tibial component came off quite easily as well with minimal bone loss. Patella was also removed. Later new implants were implanted which includes antibiotic spacer.

 
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Brand NameNEXGEN FEMORAL COMPONENT POROUS RIGHT SIZE F
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6689844
MDR Text Key79177328
Report Number0001822565-2017-04595
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK031061
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2013
Device Catalogue Number00595201602
Device LOT Number60099853
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/20/2003
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: 07/06/2017 Patient Sequence Number: 1
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