Events

Recall of LCS COMPLETE KNEE SYSTEM - RPS FLEXION FEMORAL CEMENTED

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    59041
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Depuy orthopaedics inc. is issuing a device correction for all lots of the lcs complete rps knee system and advising surgeons that the product labeling will be revised to include a warning that states the patella must be resurfaced when using this system. according to data from the australian orthopaedic association national joint replacement registry failure to resurface the patella has been associated with a higher incidence of postoperative patello-femoral pain potentially leading to a secondary procedure.

Device

LCS COMPLETE KNEE SYSTEM - RPS FLEXION FEMORAL CEMENTED
  • Model / Serial
    Model Catalog: 129412070 (Lot serial: ALL LOTS); Model Catalog: 129412060 (Lot serial: ALL LOTS); Model Catalog: 129412050 (Lot serial: ALL LOTS); Model Catalog: 129412040 (Lot serial: ALL LOTS); Model Catalog: 129412030 (Lot serial: ALL LOTS); Model Catalog: 129412020 (Lot serial: ALL LOTS); Model Catalog: 129412010 (Lot serial: ALL LOTS); Model Catalog: 129411070 (Lot serial: ALL LOTS); Model Catalog: 129411060 (Lot serial: ALL LOTS); Model Catalog: 129411050 (Lot serial: ALL LOTS); Model Catalog: 129411040 (Lot serial: ALL LOTS); Model Catalog: 129411030 (Lot serial: ALL LOTS); Model Catalog: 1294-16-622 (Lot serial: ALL LOTS); Model Catalog: 1294-16-620 (Lot serial: ALL LOTS); Model Catalog: 1294-16-617 (Lot serial: ALL LOTS); Model Catalog: 1294-16-615 (Lot serial: ALL LOTS); Model Catalog: 1294-16-612 (Lot serial: ALL LOTS); Model Catalog: 1294-16-610 (Lot serial: ALL LOTS); Model Catalog: 1294-16-525 (Lot serial: ALL LOTS); Model Catalog: 1294-16-522 (Lot serial: ALL LOTS); Model Catalog: 1294-16-520
  • Product Description
    LCS COMPLETE KNEE - RPS FLEXION FEMORAL
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.