MAUDE Adverse Event Report: ZIMMER, INC. COONRAD/MORREY ELBOW HUMERAL ASSEMBLY

Catalog Number 32810502504

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/04/2014

Event Type  Injury  

Event Description

It is reported the patient was revised to remove a broken pin and plastic due to a grinding in her elbow.

Manufacturer Narrative

Information was received via (b)(4).This report will be amended when our investigation is complete.

• Brand Name: COONRAD/MORREY ELBOW HUMERAL ASSEMBLY
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4291244
• MDR Text Key: 5084551
• Report Number: 1822565-2014-01652
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Catalogue Number: 32810502504
• Device Lot Number: 60524798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention