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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC COONRAD MORREY HUMERAL ASSEMBLY JDC

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ZIMMER INC COONRAD MORREY HUMERAL ASSEMBLY JDC Back to Search Results
Catalog Number 32810502504
Device Problem Noise, Audible (3273)
Patient Problem Irritation (1941)
Event Type  Injury  
Manufacturer Narrative
(b)(4). This report will be amended when our investigation is complete.
 
Event Description
It is reported that the patient is scheduled to be revised due to a clicking noise and irritation of the ulnar nerve believed to be caused by a worn out bushing.
 
Manufacturer Narrative
No device is received; therefore the condition of the device is unknown. Review of the device history records did not find any deviations or anomalies. This device is used for treatment. Product history search revealed no additional complaints against the related part and lot combinations for both humeral and ulnar devices. A definite root cause cannot be determined with the information provided.
 
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Brand NameCOONRAD MORREY HUMERAL ASSEMBLY
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 Key5568003
MDR Text Key42371507
Report Number1822565-2016-01146
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeAU
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 12/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2009
Device Catalogue Number32810502504
Device Lot Number60157654
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 Received06/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2004
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: 04/11/2016 Patient Sequence Number: 1
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