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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. GENDER SOLUTIONS NK-FLEX ARTICULAR SURFACE

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ZIMMER, INC. GENDER SOLUTIONS NK-FLEX ARTICULAR SURFACE Back to Search Results
Catalog Number 00542801013
Device Problems Disassembly (1168); Fracture (1260)
Patient Problem Pain (1994)
Event Date 07/20/2015
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is reported that the patient was revised due to the articular surface disengaging.

 
Manufacturer Narrative

This device is used for treatment. Visual inspection confirmed that the locking tab is broken off into two pieces. The posterior and anterior surfaces of the device show wear marks. The locking feature appears to be compressed and discoloration of the surface of the device can also be seen. There are scratches all over the device. Review of the device history records could not be performed with the information provided. Dimensions were found conforming to print specifications where measured. 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 NameGENDER SOLUTIONS NK-FLEX ARTICULAR SURFACE
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 Key5006715
MDR Text Key23262406
Report Number1822565-2015-01489
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
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 07/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00542801013
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/27/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2015
Was Device Evaluated By Manufacturer? Yes
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: 08/13/2015 Patient Sequence Number: 1
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