MAUDE Adverse Event Report: ZIMMER INC NEXEL ELBOW HUMERAL STEM; JDC

Catalog Number 00840004510

Device Problem Malposition of Device (2616)

Patient Problem Loss of Range of Motion (2032)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised due to the patient experiencing a limited range of flexion from the anterior flange being placed posteriorly.

Manufacturer Narrative

No device or photos were received; therefore the condition of the device is unknown.Device history records review indicates that the device was were manufactured to specifications.This device is used for treatment.Operative notes were requested but not provided.Initial product history search revealed no additional complaints against the related part and lot combination.It is stated by the surgeon that anterior flange was placed posterior.It is stated in surgical technique; "before fully seated, wedge a bone graft between the flange of the humeral component and the anterior distal humeral cortex." user error likely caused the event.

• Brand Name: NEXEL ELBOW HUMERAL STEM
• Type of Device: JDC
• 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: 5554948
• MDR Text Key: 42084120
• Report Number: 1822565-2016-00957
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00840004510
• Device Lot Number: 63012568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• 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): Required Intervention