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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. COONRAD/MORREY EXTRA SMALL 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 10/20/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Recall has been reported, however correction/removal reporting number has not been received to date. The reported event is confirmed. The humeral assembly is returned for evaluation. As received, the bushings are missing from the humeral device. A gouge/scratch damage seen on the yoke. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Root cause can not be determined at this time, however actions are in place, and device is involved in reported recall. 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
The customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. (b)(4).
 
Event Description
It is reported that the polyethylene bushing was not included in the packaging. This event resulted in a surgical delay of fifteen minutes or less to complete the procedure with another device.
 
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Brand NameCOONRAD/MORREY EXTRA SMALL 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 Key7044534
MDR Text Key257973775
Report Number0001822565-2017-07916
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 company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2017
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 NARRATIVE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2018
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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