MAUDE Adverse Event Report: ZIMMER VERSYS ADVOCATE FEMORAL STEM

Catalog Number 00785001200

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 05/08/2012

Event Type  Injury  

Event Description

It is reported that the pt was revised due to pain and loosening of the femoral stem.

Manufacturer Narrative

Info was received from a consumer who is not required to complete form 3500a.This event was originally submitted as mdr 1822565-2014-00234.This report will be amended when our investigation is complete.

• Brand Name: VERSYS ADVOCATE FEMORAL STEM
• Manufacturer (Section D): ZIMMER; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 3735565
• MDR Text Key: 20975362
• Report Number: 2648920-2014-00065
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 00785001200
• Device Lot Number: 60699049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• 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: 73 YR