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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TURPEAUX INDUSTRIAL PARK COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE ULNAR ASSEMBLY JDC

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TURPEAUX INDUSTRIAL PARK COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE ULNAR ASSEMBLY JDC Back to Search Results
Model Number N/A
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Date 06/23/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). This report will be amended when our investigation is complete.
 
Event Description
It is reported a patient will be revised due to loosening.
 
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Manufacturer Narrative
No device or photos were received; therefore the condition of the component is unknown. Review of the device history records did not find any deviations or anomalies. This device is used for treatment. It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. The implants were in vivo for more than 2 years. Product history search revealed no additional complaints against the related part and lot combination. A definite root cause cannot be determined with the information provided.
 
Event Description
It is reported the patient's elbow arthroplasty was revised due to loosening.
 
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Brand NameCOONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE ULNAR ASSEMBLY
Type of DeviceJDC
Manufacturer (Section D)
TURPEAUX INDUSTRIAL PARK
rt. #1, km 123.4
bldg. #1
mercedita PR 00715
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5554728
MDR Text Key42073447
Report Number1822565-2016-00967
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,Followup,Followup
Report Date 03/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2015
Device Model NumberN/A
Device Catalogue Number32810509301
Device Lot Number61507490
Other Device ID NumberN/A
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 Received08/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2010
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: 04/07/2016 Patient Sequence Number: 1
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