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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NEXEL TOTAL ELBOW HUMERAL COMPONENT ELBOW PROSTHESIS

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ZIMMER, INC. NEXEL TOTAL ELBOW HUMERAL COMPONENT ELBOW PROSTHESIS Back to Search Results
Catalog Number 00840004410
Device Problem Insufficient Information (3190)
Patient Problem Fall (1848)
Event Date 05/13/2016
Event Type  Injury  
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Event Description
It is reported that a patient was revised due to a fall where she broke her humerus mid-shaft.
 
Manufacturer Narrative
No device or photos were received; therefore the condition of the component is 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. Product history search revealed no additional complaints against the related part and lot combination. It is likely that the alleged patient fall contributed to the bone fracture.
 
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Brand NameNEXEL TOTAL ELBOW HUMERAL COMPONENT
Type of DeviceELBOW 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 Key5729391
MDR Text Key47528137
Report Number0001822565-2016-02080
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 05/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00840004410
Device Lot Number63006549
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 Received08/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2015
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: 06/16/2016 Patient Sequence Number: 1
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