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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 EXTRA SMALL PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY EXTRA SMALL 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 11/09/2017
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 was confirmed through investigation of the reported event. No products were returned; therefore, the visual and dimensional inspections were not performed. 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
(b)(4). 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). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was implanted in the patient. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent a total elbow arthroplasty. Following the opening of the package it was noticed that in the 4¿ extra small humeral component kit the poly bush was missing from the package. When the surgeon noticed the poly bush missing, the humeral component has been already implanted, and the cement had hardened. To complete the surgery, the surgeon had to open a 4¿ small humeral component kit to take the poly bush. The surgeon then assembled it with the implanted humeral and ulna components. The size mismatch (small and extra small) was resolved by trimming off the poly bush. The event resulted in a 10 minute delay. No patient impact.
 
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Brand NameCOONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY EXTRA SMALL
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 Key7099710
MDR Text Key257579250
Report Number0001822565-2017-08260
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,Followup
Report Date 02/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2017
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 Number(01)00889024274006
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 Received02/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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