MAUDE Adverse Event Report: ZIMMER INC NEXGEN LCCK ARTICULAR SURFACE; NJL

Catalog Number 00599403210

Device Problems Difficult to Insert (1316); Device Operates Differently Than Expected (2913); Scratched Material (3020)

Patient Problem No Information (3190)

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the articular surface implant failed to seat properly when trialed.

Manufacturer Narrative

This report is being filed to relay additional information.Visual inspection of the returned components identified gouges and scratches in the polyethylene around the locking hole of the articular surface.Dimensions were found conforming to print specifications where measured for both the articular surface and the locking screw.Functional testing verified that the returned screw accepted the thread ring gauge.A functional check with a tibial implant confirmed that the articular surface could be rotated slightly once implemented in the tibial tray.The device history records for the articular surface with the securing screw with subcomponent item were reviewed and no deviations or anomalies were identified this device is used for treatment.A complaint history search identified no other complaint for the part/lot combination of the articular surface.The reporter stated that the proper surgical technique was employed and that a second articular surface was opened and mated well with the tibial component.Therefore, it was concluded that there was no issue with the tibial component used by the surgeon.A definitive root cause cannot be determined with the information provided.

• Brand Name: NEXGEN LCCK ARTICULAR SURFACE
• 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: 5594147
• MDR Text Key: 43226558
• Report Number: 0001822565-2016-01249
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK960279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 00599403210
• Device Lot Number: 63081954
• Other Device ID Number: 00889024225022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1