MAUDE Adverse Event Report: ZIMMER, BUILDING #2 NEXGEN LPS-FLEX FEMORAL COMPONENT; NJL

Catalog Number 00596401752

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

Patient Problem No Information (3190)

Event Date 12/11/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received for evaluation.Visual examination did not confirm the presence of any polyethylene or adhesive.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 (b)(4) was initiated on january 11, 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 implant was opened and prepped for implantation.The surgeon noticed the polyethylene plastic bag was adhered to the femoral component.The device was not implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: NEXGEN LPS-FLEX FEMORAL COMPONENT
• Type of Device: NJL
• Manufacturer (Section D): ZIMMER, BUILDING #2; east park, shannon industrial; estate,shannon, co. clare,; EI
• Manufacturer (Section G): ZIMMER, BUILDING #2; east park, shannon industrial; estate,shannon, co. clare,; EI
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5651045
• MDR Text Key: 45100368
• Report Number: 3007963827-2016-00026
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP060037
• 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,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 00596401752
• Device Lot Number: 62140630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2012
• 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