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U.S. Department of Health and Human Services

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

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ZIMMER, INC. UNKNOWN ZIMMER COONRAD/MORREY HUMERAL ASSEMBLY ELBOW PROSTHESIS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Information was received from a distributor who is not required to complete form 3500a. This report will be amended when our investigation is complete.
 
Event Description
It is reported the humeral component was revised for an unknown reason.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. No device or photos were received; therefore the condition of the device is unknown. Device history records cannot be reviewed since the device is unknown. This device is used for treatment. Product history search cannot be completed since the product is unknown. Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. A definite root cause cannot be determined with the information provided.
 
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Brand NameUNKNOWN ZIMMER COONRAD/MORREY HUMERAL ASSEMBLY
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 Key5906133
MDR Text Key53076857
Report Number0001822565-2016-02974
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,Followup
Report Date 08/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2016
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 Received11/22/2016
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

Patient Treatment Data
Date Received: 08/26/2016 Patient Sequence Number: 1
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