MAUDE Adverse Event Report: ZIMMER INC NEXGEN LPS FEMORAL COMPONENT; NJL

Catalog Number 00599601851

Device Problems Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination confirmed low density polyethylene ldpe residue on the edge of the posterior lateral condyle and the posterior aspect of the medial condyle.It was also noted that there is a blue discoloration spot on the posterior aspect of the cam and the posterior aspect of the lateral condyle.The blue discoloration could be removed with a paper towel moistened with water and is likely residue from blue contrast bone cement.The device was used for treatment.This issue has been previously investigated and as part of corrective action, a new supplier for the polyethylene bags has been selected and testing completed to ensure thermal reliability and stability of the new bags.Field action z-0845-2016 was initiated on (b)(6) 2016 to remove remaining affected units from the field.This field action contains the related part and lot number.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported that the plastic polyethylene bag adhered to the femoral implant.

• Brand Name: NEXGEN LPS FEMORAL COMPONENT
• Type of Device: NJL
• 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: 5572267
• MDR Text Key: 42607002
• Report Number: 1822565-2016-01114
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00599601851
• Device Lot Number: 62122743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0845-2016
• Patient Sequence Number: 1