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U.S. Department of Health and Human Services

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

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ZIMMER INC UNKNOWN COONRAD/MORREY ULNAR STEM ASSEMBLY ELBOW PROSTHESIS Back to Search Results
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Information was received via published journal article. Please reference literature at the following location: http://www. Ncbi. Nlm. Nih. Gov/pmc/articles/pmc3705234/. (b)(4). Operative notes were requested however none provided. Relevant medical history and adherence to rehabilitation protocol are unknown. No devices or photos were received; therefore the condition of the component is unknown. The part and lot numbers of the product are unknown; therefore the device history records could not be reviewed. The product was used for treatment. The complaint history for this product could not be reviewed due to the lack of lot numbers. It could not be confirmed if the devices used are an approved and compatible combination. A definitive root cause cannot be determined with the information provided. The investigation could not verify or identify any evidence of product contribution to the reported problem. Based on the available information, the need for corrective action is not indicated. Should additional substantive information be received, the complaint will be reopened. Zimmer biomet considers the investigation closed.
 
Event Description
It has been reported that a (b)(6) female patient with a left side replacement experienced a loose ulnar component with a loose hinge.
 
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Brand NameUNKNOWN COONRAD/MORREY ULNAR STEM 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 Key5492740
MDR Text Key40113680
Report Number1822565-2016-00642
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
Report Date 02/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2016
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 Received02/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/10/2016 Patient Sequence Number: 1
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