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U.S. Department of Health and Human Services

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

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ZIMMER, INC. UNKNOWN COONRAD-MORREY HUMERAL COMPONENT ELBOW PROSTHESIS Back to Search Results
Device Problems Detachment Of Device Component (1104); Fracture (1260); Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Sietz et al. "failure of the hinge mechanism in total elbow arthroplasty. " j shoulder elbow surg (2010). 19:368-375. 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. 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. Initial reporter - the article was written by william h. Seitz jr. , hisham bismar and peter j. Evans involving hospitals cleveland clinic hospital, kaiser permanente hospital and the cleveland clinic, ohio, united states of america.
 
Event Description
It is reported in a journal article that one patient underwent elbow arthroplasty revision due to a third instance of locking mechanism failure. The patient was revised to a more durable, custom-made locking mechanism. No further information is available.
 
Manufacturer Narrative
This follow-up report is being filed to correct information. This information does not change the investigation previously reported.
 
Event Description
It is reported in a journal article that one patient underwent elbow arthroplasty revision due to a third instance of locking mechanism failure. The patient was revised to a more durable, custom-made locking mechanism. No further information is available. Additionally, the article mentions that the failed locking mechanisms were due to either pin fracture or dissociation of the pin components. However, it is unclear for these patients, what specific failures occurred.
 
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Brand NameUNKNOWN COONRAD-MORREY HUMERAL COMPONENT
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 Key6331346
MDR Text Key67442227
Report Number0001822565-2017-00760
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2017
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: 02/15/2017 Patient Sequence Number: 1
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