MAUDE Adverse Event Report: ZIMMER INC UNKNOWN COONRAD/MORREY ULNAR STEM ASSEMBLY; ELBOW PROSTHESIS

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.Please reference literature at the following location: http://jbjs.Org/content/82/10/1379.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that one elbow was revised due to fracture of the ulnar component.

Manufacturer Narrative

No device or photos were received; therefore the condition of the device is unknown.Device history records cannot be reviewed since the part and lot number is unknown.This device is used for treatment.Product history search cannot be completed since the part and lot number is unknown.A definite root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN COONRAD/MORREY ULNAR STEM ASSEMBLY
• Type of Device: ELBOW PROSTHESIS
• 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: 5474291
• MDR Text Key: 39479209
• Report Number: 1822565-2016-00420
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/03/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 03/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention