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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 Problem Failure To Adhere Or Bond (1031)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
Morrey et al. "ulnar component surface finish influenced the outcome of primary coonrad-morrey total elbow arthroplasty. " journal title. 95:1117-1124. 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. The article was written in-ho jeon, bernard f. Morrey and joaquin sanchez-sotel.
 
Event Description
It is reported that one patient required resection due to humeral periprosthetic fracture and loosening following elbow arthroplasty. Radiographs showed a nonunion, fractured wires, and graft loosening.
 
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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 Key6331618
MDR Text Key67480968
Report Number0001822565-2017-00707
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
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? 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 Received01/16/2017
Was Device Evaluated by Manufacturer? No
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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