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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
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.
 
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.
 
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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 Key106343464
Report Number1822565-2015-01937
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
PMA/PMN Number
PK023211
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
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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