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

Catalog Number 32810502504

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2013

Event Type  malfunction  

Event Description

It is reported that the locking pin did not fit.The stem was cemented in and a replacement pin was used.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: COONRAD/MORREY HUMERAL ASSEMBLY
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46580 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46580-0708 ; 8006136131
• MDR Report Key: 4593648
• MDR Text Key: 20732936
• Report Number: 1822565-2013-01831
• 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: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 32810502504
• Device Lot Number: 62452278
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/03/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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