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

Catalog Number 00596103210

Device Problem Break (1069)

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

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the surgeon was impacting the articular surface trial with mallet when it broke.

Manufacturer Narrative

Visual evaluation of the returned provisional articular surface found that it cleanly fractured into two pieces along an antero-posterior line through one of the condylar surfaces.Several nicks, gouges and scratches can be observed all over both the superior and inferior surfaces.Dimensional evaluation found that both the height and antero-posterior width are within 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 complaint for the part and lot combination of the articular surface.Per the warnings section of the 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: 5310854
• MDR Text Key: 34352149
• Report Number: 1822565-2015-02693
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

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: 00596103210
• Device Lot Number: 62057087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2012
• 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