MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN LEGACY PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACE; KNEE, PROSTHESIS

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that the articular surface could not be completely inserted in the platform prosthesis.

Manufacturer Narrative

Concomitant medical products: femoral component option for cemented use only size d left catalog# 00599601451, lot# 63261437, tibial component stemmed precoat use of this tibial component with legacy knee - constrained condylar knee (lcck) articulating surfaces requires using catalog# 00598003701, lot# 63171975, articular surface use with lps/lps-flex 51 or 52 suffix femorals size cd 12 mm height catalog# 00596203012, lot# 62976399.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned articular surface found the dovetail feature was flared out; one side is compressed.Some scratches and gouges were found on the part.Dhr was reviewed and no discrepancies were found.It is considered that the issue was not caused by the mating tibial component as there was no report of it having to be replaced during surgery.The damage of the dovetail observed on the returned articular surface indicates that it was not correctly placed and oriented before pushing it using the inserter instrument.It is likely that the problem encountered is related to surgical technique.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NEXGEN LEGACY PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACE
• Type of Device: KNEE, PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6045571
• MDR Text Key: 58019162
• Report Number: 0002648920-2016-03217
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK042271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 00596203012
• Device Lot Number: 62976399
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• 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
• Patient Age: 54 YR