MAUDE Adverse Event Report: ZIMMER INC COONRAD MORREY HUMERAL ASSEMBLY; JDC

Catalog Number 32810502504

Device Problem Noise, Audible (3273)

Patient Problem Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is scheduled to be revised due to a clicking noise and irritation of the ulnar nerve believed to be caused by a worn out bushing.

Manufacturer Narrative

No device is received; therefore the condition of the device is unknown.Review of the device history records did not find any deviations or anomalies.This device is used for treatment.Product history search revealed no additional complaints against the related part and lot combinations for both humeral and ulnar devices.A definite root cause cannot be determined with the information provided.

• Brand Name: COONRAD MORREY HUMERAL ASSEMBLY
• Type of Device: JDC
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5568003
• MDR Text Key: 42371507
• Report Number: 1822565-2016-01146
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2009
• Device Catalogue Number: 32810502504
• Device Lot Number: 60157654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2004
• 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
• Patient Age: 45 YR