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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY PROSTHESIS ELBOW

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ZIMMER BIOMET, INC. COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY PROSTHESIS ELBOW Back to Search Results
Model Number N/A
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2017
Event Type  malfunction  
Manufacturer Narrative
Reported event was able to be confirmed via complaint history review. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. A definite root cause has not yet been determined, however, remedial action has been initiated. No correction//removal number has been received. 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)(4). (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation as it remains implanted in the patient. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during a surgery, the surgeon found the poly bushing missing from a brand new humeral component package. The surgery was completed with a poly bush from another package. No adverse events have been reported as a result of the malfunction.
 
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Brand NameCOONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY
Type of DevicePROSTHESIS ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7104200
MDR Text Key253866805
Report Number0001822565-2017-08337
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
PK001989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number32810502704
Device Lot Number63694912
Other Device ID NumberSEE H10
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 Received03/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2017
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

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