MAUDE Adverse Event Report: ZIMMER INC NEXGEN LPS-FLEX ART SURFACE PROVISIONAL; HWT

Catalog Number 00596104210

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It was reported that the provisional articular surface broke when the physician was placing it into the tibial baseplate using a mallet.

Manufacturer Narrative

Visual inspection of the returned component found that the articular surface was broken in two pieces.The fracture line extended in the antero-posterior direction from a mid-sagittal point on the edge of the screw hole, through a condylar surface near the base of the post, and toward the posterior notch.The height of the articular surface was found conforming to print specifications.The device history records were reviewed with no deviations/ anomalies identified.This device is used for treatment.A product history search identified no other complaints for the part and lot combination of the articular surface.Per the warnings section of the instrument/provisional use, care and sterilization package insert, users are instructed not to subject instruments to high loads and/or impact as breakage can occur.The breakage problem was caused by hammering the device, which is instructed against.Therefore, user error is considered to be the root cause.

• Brand Name: NEXGEN LPS-FLEX ART SURFACE PROVISIONAL
• Type of Device: HWT
• 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: 5271658
• MDR Text Key: 32894493
• Report Number: 1822565-2015-02571
• Device Sequence Number: 1
• Product Code: HWT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00596104210
• Device Lot Number: 62057155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 12/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1