MAUDE Adverse Event Report: ZIMMER, INC. VERSYS FEMORAL STEM

Catalog Number 00784101430

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 09/06/2013

Event Type  Injury  

Event Description

It is reported the pt was revised due to pain and the femoral stem becoming loose.

Manufacturer Narrative

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

• Brand Name: VERSYS FEMORAL STEM
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4411661
• MDR Text Key: 5372039
• Report Number: 1822565-2015-00002
• Device Sequence Number: 1
• Product Code: MRA
• 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: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 00784101430
• Device Lot Number: 60234811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2005
• 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 Weight: 54