MAUDE Adverse Event Report: ZIMMER INC VERSYS FEMORAL STEM; MEH

Catalog Number 65764501400

Device Problems Failure To Adhere Or Bond (1031); Corroded (1131)

Patient Problem No Information (3190)

Event Date 01/08/2016

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 stem loosening.Black foreign matter was found in the fitting portion of the stem.

• Brand Name: VERSYS FEMORAL STEM
• Type of Device: MEH
• 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: 5454578
• MDR Text Key: 38813061
• Report Number: 1822565-2016-00381
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 65764501400
• Device Lot Number: 60479759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2006
• 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