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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC NEXEL TOTAL ELBOW HUMERAL STEM JDC

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ZIMMER INC NEXEL TOTAL ELBOW HUMERAL STEM JDC Back to Search Results
Catalog Number 00840004410
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 10/10/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: catalog #00840009400, nexel articulation kit, lot #63033976; catalog #00840009000, nexel humeral screw kit, lot #62933127. This report will be amended when our investigation is complete.
 
Event Description
It is reported the patient underwent a two-stage revision for infection; the first state occuring on (b)(6) 2015 and the second stage occurring on (b)(6) 2016.
 
Manufacturer Narrative
No devices or photos were received; therefore the condition of the components is unknown. Review of the device history records did not find any deviations or anomalies. These devices are 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 other complaints for infection for the related part and lot combinations. Patient's activity level and adherence to rehabilitation protocol is unknown. Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1. 0 x 10-6 or better. Therefore, it is highly unlikely that the specified device caused or contributed to any patient infection. A definite root cause cannot be determined with the information provided.
 
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Brand NameNEXEL TOTAL ELBOW HUMERAL STEM
Type of DeviceJDC
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 Key5547672
MDR Text Key41885522
Report Number1822565-2016-00880
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 03/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00840004410
Device Lot Number62918657
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2015
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: 04/05/2016 Patient Sequence Number: 1
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