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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NEXEL ELBOW HUMERAL STEM HIP PROSTHESIS

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ZIMMER, INC. NEXEL ELBOW HUMERAL STEM HIP PROSTHESIS Back to Search Results
Catalog Number 00840004510
Device Problems Failure To Adhere Or Bond (1031); Particulates (1451)
Patient Problem No Code Available (3191)
Event Date 07/20/2016
Event Type  Injury  
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Event Description
It was reported that a patient under went revision of the humeral component due to loosening. It was noticed during revision that the polyethylene had metal particles embedded within it.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. No device or photos were received; therefore the condition of the device is unknown. A device history records review indicates device was manufactured to specifications. This device is used for treatment. Initial product history search was conducted and revealed no additional complaints against the related part and lot combination. 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 definite root cause cannot be determined with the information provided.
 
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Brand NameNEXEL ELBOW HUMERAL STEM
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
carrie schneider
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5886487
MDR Text Key52441927
Report Number0001822565-2016-02884
Device Sequence Number1
Product Code JDC
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 07/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00840004510
Device Lot Number77002575
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 Received12/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/18/2016 Patient Sequence Number: 1
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