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U.S. Department of Health and Human Services

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

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ZIMMER, INC. UNKNOWN COONRAD-MORREY ELBOW ULNAR COMPONENT ELBOW PROSTHESIS Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Code Available (3191)
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 Description
It is reported that the patient is indicated for elbow arthroplasty revision due to loosening of the ulnar component. No revision 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. Implant date - patient was initially implanted sometime in 2013. 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
It is reported that the patient is indicated for elbow arthroplasty revision approximately four years post-implantation due to loosening of the ulnar component. No revision has been reported to date.
 
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Brand NameUNKNOWN COONRAD-MORREY ELBOW ULNAR 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 Key6305902
MDR Text Key66656163
Report Number0001822565-2017-00517
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,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2017
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: 02/06/2017 Patient Sequence Number: 1
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