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U.S. Department of Health and Human Services

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

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ZIMMER, INC. UNKNOWN COONRAD MORREY HUMERAL COMPONENT PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Additional: reported event was unable to be confirmed due to limited information received from the customer. Device history record review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
(b)(6). The product will not be returned to zimmer biomet for analysis, as this facility keeps explanted products; however, an investigation has been initiated. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It is reported that patient has been indicated for a left elbow revision of the humeral component due to loosening; however, no revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN COONRAD MORREY HUMERAL COMPONENT
Type of DevicePROSTHESIS, ELBOW
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 Key6788254
MDR Text Key134106694
Report Number0001822565-2017-05577
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
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 09/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
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 Received07/17/2017
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/11/2017 Patient Sequence Number: 1
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