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

Catalog Number 00596001651

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2013

Event Type  malfunction  

Manufacturer Narrative

Information was received from a surgeon who is not required to complete form 3500a.The device was not returned for evaluation.Device history records for the lot were reviewed and found to be conforming requirements at the time of manufacture.Independent lab testing has confirmed that the residue is non-toxic.Zimmer has done testing that shows that the residue can be removed using a soft cloth moistened with water or isopropyl alcohol.Biocompatibility testing has determined that there exists a negligible risk to the patient associated with the sticky bag occurrence.The device was used for treatment.The femoral component was packaged with a raw material lot of polyethylene bags that was previously identified as having the potential to adhere to highly polished surfaces, which may leave a residue and in some cases a portion of polyethylene on the device.Many factors have been identified that lead to the sticky bag occurrence, such as the size of the implant, the time of the year the product was packaged and the material formulation of the polyethylene bags.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.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.Device not returned.

Event Description

It was reported that the surgeon found plastic residue on the implant during surgery.A new implant was opened and surgery was completed with the new implant.There was no patient harm or surgical delay.

• 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: 5572498
• MDR Text Key: 42495849
• Report Number: 1822565-2016-01039
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2013

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 Expiration Date: 05/31/2020
• Device Catalogue Number: 00596001651
• Device Lot Number: 61517270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2010
• 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