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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NEXEL TOTAL ELBOW ULNAR COMPONENT JDC

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ZIMMER, INC. ZIMMER NEXEL TOTAL ELBOW ULNAR COMPONENT JDC Back to Search Results
Model Number N/A
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Event Description
It is reported an x-ray showed radiolucency lines around the ulnar stem following elbow arthroplasty. A revision surgery is pending.
 
Manufacturer Narrative
No device or photos were received since the device still remains implanted, therefore the condition of the component is unknown. Review of the device history records did not find any deviations or anomalies. Immediate post-operative, 4 months follow up and 1 year follow up x-rays were provided for review. Third party review of the x-rays confirms radiolucency and migration of the ulnar stem with cortical breakthrough tip of the ulnar stem and associated periosteal callus. It was noted in the x-ray review that ¿total elbow replacement demonstrates progressive loosening of the ulnar stem component. The loosening is most likely due to aseptic loosening or septic loosening. The orientation and placement of the implants on the immediate post-operative x-rays is typical. ¿ 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. Patient¿s adherence to rehabilitation protocol is unknown. A definite root cause cannot be determined with the information provided.
 
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Brand NameZIMMER NEXEL TOTAL ELBOW ULNAR COMPONENT
Type of DeviceJDC
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 Key5685631
MDR Text Key46110727
Report Number0001822565-2016-01837
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00840002511
Device Lot Number62541146
Other Device ID NumberN/A
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 Received10/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/02/2014
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: 05/27/2016 Patient Sequence Number: 1
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