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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER EXTREMEITY ELBOW PROSTHESIS

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ZIMMER, INC. UNKNOWN ZIMMER EXTREMEITY ELBOW PROSTHESIS Back to Search Results
Device Problem Biocompatibility (2886)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Event Description
It was reported that a male patient underwent a left total elbow arthroplasty. The patient will undergo revision, due to disease progression on the ulna side.
 
Manufacturer Narrative
Information has been received and it has been found the experience reported is not alleging a deficiency against any of zimmer biomet's products. The reported product did not cause or contribute to the event. Zimmer considers this investigation closed.
 
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Brand NameUNKNOWN ZIMMER EXTREMEITY
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 Key5825769
MDR Text Key50535779
Report Number0001822565-2016-02586
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 07/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2016
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/27/2016 Patient Sequence Number: 1
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