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U.S. Department of Health and Human Services

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

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ZIMMER, INC. COONRAD/MORREY ELBOW ULNA PROSTHESIS, ELBOW Back to Search Results
Catalog Number UNKNOWN
Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Erosion (1750); Failure of Implant (1924); No Information (3190); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Foreign - (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
No additional event update has been received at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. No additional information has been obtained pertaining to this event, therefore, the root cause remains as is.
 
Event Description
No event update is available at the time of this report.
 
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Event Description
It is reported the patient was revised following an elbow arthroplasty due to unknown reasons.
 
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.
 
Manufacturer Narrative
This follow-up report is being filed to correct information. This information does not change the root cause of the investigation previously reported.
 
Event Description
It is reported that the patient is being considered for right elbow arthroplasty revision due to loosening of the ulnar component and bone loss and/or erosion. No further information is available.
 
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Brand NameCOONRAD/MORREY ELBOW ULNA
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
kathleen smith
p.o. box 708
warsaw, IN 46580
8006136131
MDR Report Key6090179
MDR Text Key291626067
Report Number0001822565-2016-04141
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2016
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: 11/09/2016 Patient Sequence Number: 1
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