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 02/04/2014

Event Type  malfunction  

Event Description

It was reported that the doctor had difficulty putting in the hinge pin.Due to this taking so much time, the humeral stem was implanted 10mm from the planned position.

Manufacturer Narrative

Evaluation summary: it has been reported that the surgeon had difficulty assembling the inner and outer pin.No devices or photos were received therefore a determination on the condition of the devices not could be made.All devices from this lot have been distributed with no other complaints or any type.Cause cannot be definitively determined.Review of the device history records did not find any deviations or anomalies.It is not suspected that the product failed to meet specifications.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the investigation, the need for corrective action is not indicated.Should additional substantive information be received, the complaint will be reopened.Zimmer, inc considers the investigation closed.

• Brand Name: COONRAD MORREY HUMERAL ASSEMBLY
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 3829933
• MDR Text Key: 18734602
• Report Number: 1822565-2014-00340
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 32810502504
• Device Lot Number: 61988391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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