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

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

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 for revision surgery for an unknown reason.The patient is being revised to a custom distal humerus component.

Manufacturer Narrative

No devices or photos were returned therefore a determination on the condition of the devices could not be made.The devices part numbers and lot number were not provided therefore their device history records could not be reviewed and a complaint search could not be performed.The devices were used for treatment.With the provided information an exact cause could not be determined.

• Brand Name: UNKNOWN ZIMMER COONRAD MORREY ELBOW
• 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: 5278189
• MDR Text Key: 33043220
• Report Number: 1822565-2015-02623
• Device Sequence Number: 1
• Product Code: KWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other