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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC UNKNOWN COONRAD/MORREY ULNAR ASSEMBLY ELBOW PROSTHESIS

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ZIMMER INC UNKNOWN COONRAD/MORREY ULNAR ASSEMBLY ELBOW PROSTHESIS Back to Search Results
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Information was received via published literature. Please reference literature at the following location: http://www. Ncbi. Nlm. Nih. Gov/pubmed/26920964 (b)(4) this report will be amended when our investigation is complete.
 
Event Description
It is reported that one patient has type 0 ulnar radiolucency.
 
Manufacturer Narrative
There was no product returned; therefore, no physical evaluation could be conducted. The device history records could not be reviewed due to lack of product identification; the lot number required for retrieval was unavailable. This device is used for treatment. The investigation could not identify or verify any evidence of product contribution to the reported problem. This complaint could not be confirmed.
 
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Brand NameUNKNOWN COONRAD/MORREY ULNAR ASSEMBLY
Type of DeviceELBOW PROSTHESIS
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 Key5552260
MDR Text Key42012031
Report Number1822565-2016-00933
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUK
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 03/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/06/2016 Patient Sequence Number: 1
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