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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 00595201602
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 11/07/2013
Event Type  Injury  
Manufacturer Narrative

(b)(4). No devices or pictures have been returned for review. The device history records for the femoral implant were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified. This device is used for treatment. Surgical notes were not provided. X-rays were not provided; it is unknown whether the devices were implanted with the correct fit and orientation as per the surgical technique. A complaint history search found no other complaints against the femoral implant part/lot combination. A definitive root cause cannot be determined with the information provided.

 
Event Description

It is reported that the patient's knee device "began to degrade, loosen, and fail. " subsequently, a two stage revision was undertaken. In the two step process, the patient contracted a staph infection and fell ill. He was in hospital for 12 days following the surgery and was then admitted to a skilled nursing unit for some months where he received intensive antibiotic treatment.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Concomitant medical products ¿ all poly patella catalog 00597206535 lot 60107540; nexgen tibial component catalog 00598204702 lot 54071300; nexgen articular surface catalog 90597004014 lot 56286800; self tapping bone screw catalog 00511007030 lot 25005800; self tapping bone screw catalog 00511007040 lot 20132000; self tapping bone screw catalog 00511007040 lot 21093200.

 
Event Description

It is reported that the patient's knee device "began to degrade, loosen, and fail. " subsequently, a two stage revision was undertaken. In the two step process, the patient contracted a staph infection and fell ill. He was in hospital for 12 days following the surgery and was then admitted to a skilled nursing unit for some months where he received intensive antibiotic treatment. Operative notes provided state that the patient underwent the first stage of the revision to remove a competitor intramedullary nail as the first stage of a revision procedure due to loosening.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. The reported event was confirmed from medical records received. No devices were received; therefore the condition of the components is unknown. Dhr was reviewed and no discrepancies relevant to the reported event were found. As per package insert nexgen cr-flex (fixed and mobile bearing)/lps-flex (fixed and mobile bearing)/lps-mobile, loosening is known risk of these procedures. A definitive root cause cannot be determined with the information provided. 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.

 
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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 Key5087207
MDR Text Key26153840
Report Number1822565-2015-01937
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
PMA/PMN NumberPK023211
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2015
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2018
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: 09/18/2015 Patient Sequence Number: 1
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