• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER MANUFACTURING B.V. NEXGEN LEGACY PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACE KNEE, PROSTHESIS Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEXGEN LEGACY PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACE
Type of DeviceKNEE, 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 Key6045571
MDR Text Key58019162
Report Number0002648920-2016-03217
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberPK042271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2020
Device MODEL NumberN/A
Device Catalogue Number00596203012
Device LOT Number62976399
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/19/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/12/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

-
-