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

Device Problem Insufficient Information (3190)

Patient Problem Ossification (1428)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.Please reference literature at the following location: http://www.Ncbi.Nlm.Nih.Gov/pubmed/26920964.(b)(4).Other device used: catalog #unk, unknown coonrad/morrey ulnar assembly, lot #unk.This report will be amended when our investigation is complete.

Event Description

It is reported that three patients experienced heterotopic ossification.

Manufacturer Narrative

There was no product returned; therefore, no physical evaluation could be conducted.The device history records could not be reviewed due to lack of product identification; the lot number required for retrieval was unavailable.This device is used for treatment.The investigation could not identify or verify any evidence of product contribution to the reported problem.This complaint could not be confirmed.Based on the available information, the need for corrective action is not indicated.

• Brand Name: UNKNOWN COONRAD/MORREY HUMERAL 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: 5552306
• MDR Text Key: 42028785
• Report Number: 1822565-2016-00936
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• 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
• Date Manufacturer Received: 06/13/2016
• 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): Other