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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER COONRAD/MORREY ELBOW ELBOW PROSTHESIS

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ZIMMER, INC. UNKNOWN ZIMMER COONRAD/MORREY ELBOW ELBOW PROSTHESIS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
No device or photos were received; therefore the condition of the device is unknown. Device history records cannot be reviewed since the part and lot number is unknown. This device is used for treatment. Product history search cannot be completed since the part and lot number is unknown. A definite root cause cannot be determined with the information provided.
 
Event Description
It is reported a patient will be revised for an unknown reason.
 
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Brand NameUNKNOWN ZIMMER COONRAD/MORREY ELBOW
Type of DeviceELBOW PROSTHESIS
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 Key5752107
MDR Text Key48256749
Report Number0001822565-2016-02159
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 06/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2016
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 Received06/01/2016
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: 06/27/2016 Patient Sequence Number: 1
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