MAUDE Adverse Event Report: ZIMMER COONRAD / MORREY; TOTAL ELBOW

Lot Number 60524798

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 08/04/2014

Event Type  Injury  

Event Description

Pt with history of left total elbow (b)(6) 2007.Coonrad/morrey total elbow interchangeable humeral assembly small inplant.In (b)(6) 2014, pt complained of "grinding" in her elbow.Xray showed broken pin.On (b)(6) 2014, pt had revision left elbow with removal of pin and plastic hardware.Dates of use: (b)(6) 2007 - (b)(6) 2014.

• Brand Name: COONRAD / MORREY
• Type of Device: TOTAL ELBOW
• Manufacturer (Section D): ZIMMER; warsaw IN
• MDR Report Key: 3999659
• MDR Text Key: 4708654
• Report Number: MW5037685
• Device Sequence Number: 1
• Product Code: JDC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/05/2014

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
• Device Lot Number: 60524798
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 70