MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER SEGMENTAL VSS STEM EXTENSION

Catalog Number 00585207015

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Unspecified Infection (1930); No Information (3190)

Event Date 01/10/2015

Event Type  Injury  

Event Description

It is reported that the pt was revised due to loosening, severe metallosis, and an outside-in infection from needle into wound by pt.At surgery, severe metallosis was seen from femoral stem pistoning inside the femur.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: ZIMMER SEGMENTAL VSS STEM EXTENSION
• 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: 4510864
• MDR Text Key: 15123628
• Report Number: 1822565-2015-00145
• Device Sequence Number: 1
• Product Code: LZO
• 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: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 00585207015
• Device Lot Number: 61265420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• 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: 38 YR
• Patient Weight: 50