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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT KNEE PROSTHESIS

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ZIMMER INC UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT KNEE PROSTHESIS Back to Search Results
Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative

Information was received via published literature. (b)(4). This report will be amended when our investigation is complete. Please reference literature at the following location: http://www. Ncbi. Nlm. Nih. Gov/pmc/articles/pmc3613521/.

 
Event Description

It is reported that progressive radiolucent lines about components and radiologic component loosening or migration was observed in 2 femurs.

 
Manufacturer Narrative

Device history records could not be reviewed as the part and lot numbers are unknown. This device is used for treatment. Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. A definitive root cause cannot be determined with the information provided.

 
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Brand NameUNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT
Type of DeviceKNEE PROSTHESIS
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 Key5046362
MDR Text Key24727643
Report Number1822565-2015-01620
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received09/11/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/01/2015 Patient Sequence Number: 1
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