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

Catalog Number 00783401600

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 08/25/2014

Event Type  Injury  

Event Description

It is reported the patient was revised due to stem loosening.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: VERSYS FEMORAL STEM PRESS-FIT
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4142791
• MDR Text Key: 4913334
• Report Number: 1822565-2014-01172
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 00783401600
• Device Lot Number: 60227423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 09/23/2014
• 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 Age: 66 YR
• Patient Weight: 91