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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC UNKNOWN HUMERAL STEM ASSEMBLY ELBOW PROSTHESIS

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ZIMMER INC UNKNOWN HUMERAL STEM ASSEMBLY ELBOW PROSTHESIS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 06/13/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). This report will be amended when our investigation is complete.
 
Event Description
It is reported that a revision surgery is scheduled for unknown reasons.
 
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Event Description
It is reported the patient has a revision surgery scheduled for a loose humeral component.
 
Manufacturer Narrative
No device or photos were received; therefore the condition of the component is unknown. Device history records cannot be reviewed since the part and lot number is unknown. This device is used for treatment. Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. Product history search cannot be completed since the part and lot number is unknown. Patient activity level and adherence to rehabilitation protocol is unknown. A definite root cause cannot be determined with the information provided.
 
Event Description
It is reported the patient was revised due to loosening of the humeral component.
 
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Brand NameUNKNOWN HUMERAL 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 Key5550896
MDR Text Key41979221
Report Number1822565-2016-00921
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/15/2016
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2016
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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