MAUDE Adverse Event Report: ZIMMER, INC. KINECTIV TECHNOLOGY MODULAR NECK

Catalog Number 00784802301

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 03/15/2013

Event Type  Injury  

Event Description

It is reported the pt was revised due to signs of impingent.

Manufacturer Narrative

Info was received from a foreign source who is not required to complete form 3500a.This report will be amended when our investigation is complete.

• Brand Name: KINECTIV TECHNOLOGY MODULAR NECK
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46580 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46580-0708 ; 8006136131
• MDR Report Key: 4122348
• MDR Text Key: 4919202
• Report Number: 1822565-2014-01153
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 00784802301
• Device Lot Number: 60867802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2008
• 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
• Patient Age: 50 YR
• Patient Weight: 110