MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMEMR COONRAD/MORREY PIN; ELBOW PROSTHESIS

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

It is reported that the hinge pin is broken.A revision surgery is planned.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: UNKNOWN ZIMEMR COONRAD/MORREY PIN
• Type of Device: ELBOW PROSTHESIS
• 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: 4114238
• MDR Text Key: 16173011
• Report Number: 1822565-2014-01148
• 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: Physician
• Type of Report: Initial
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 50 YR
• Patient Weight: 159