Events

Recall of Device Recall DePuy Orthopaedics LCS COMPLETE RPS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Orthopaedics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71085
  • Event Risk Class
    Class 2
  • Event Number
    Z-1672-2015
  • Event Initiated Date
    2015-03-04
  • Event Date Posted
    2015-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136057
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing - Product Code NJL
  • Reason
    The lcs complete rps knee system has higher rates of revision in australia when the native patella is not resurfaced when compared to other unresurfaced ps implants. if the lcs complete rps knee system is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.
  • Action
    On 3/4/2015, URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System and on 3/19/2015 REVISED URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System (Revised) notifications were sent to the affected distributors and medical professionals. All distributors were notified via electronic mail, and all medical professionals with affected inventory were also notified by distributor or Sales Consultant via in person delivery or mail or electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. to 5 p.m. EDT).

Device

Device Recall DePuy Orthopaedics LCS COMPLETE RPS
  • Model / Serial
    All Lots. Catalog numbers: 129411010 129411020 129411030 129411040 129411050 129411060 129411070 129412010 129412020 129412030 129412040 129412050 129412060 129412070 129495040 129495050 129495060 129496040 129496050 129496060
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of CANADA, AUSTRALIA, AUSTRIA, BELGIUM, UK, FRANCE, GREECE, IRELAND, ISRAEL, ITALY, KOREA, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, SOUTH AFRICA, SWITZERLAND, THAILAND.
  • Product Description
    LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA