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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 Problem No Code Available (3191)
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. Compatibility of the implants was reviewed with no issues found. A definitive root cause cannot be determined with the information provided.
 
Event Description
It is reported that the patient's components "began to degrade, loosen, and fail. ".
 
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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 Key5085933
MDR Text Key26110276
Report Number1822565-2015-01936
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
Report Date 08/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00595201601
Device Lot Number60063377
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/17/2015 Patient Sequence Number: 1
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