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U.S. Department of Health and Human Services

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

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ZIMMER, INC. UNKNOWN COONRAD/MORREY ELBOW IMPLANT ELBOW PROSTHESIS Back to Search Results
Device Problems Material Erosion (1214); Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 12/22/2016
Event Type  Injury  
Manufacturer Narrative
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure may be necessary. Should additional information be received regarding a revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.
 
Event Description
It is reported that the patient is indicated for elbow arthroplasty revision due to unknown reasons. No revision procedure has been reported to date.
 
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 lot number is unknown. This device is used for treatment. Product history search cannot be completed since the lot number 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.
 
Event Description
Patient underwent elbow revision approximately eleven to thirteen years post-operatively due to a worn bushing. The bushing was removed and replaced.
 
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Brand NameUNKNOWN COONRAD/MORREY ELBOW IMPLANT
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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6146013
MDR Text Key61467406
Report Number0001822565-2016-04543
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received01/09/2017
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: 12/05/2016 Patient Sequence Number: 1
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