Events

Safety Alert for Cemented, Polished and Cobalt Chromium Alloy Hip Stems

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by DePuy.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-05-03
  • Event Date Posted
    2012-05-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120503f.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: depuy cemented, polished and cobalt chromium alloy hip stems it comes to our attention that medical device manufacturer, depuy (a johnson & johnson company) has issued a field safety notice concerning depuy cemented, polished and cobalt chromium alloy hip stems. in 2007, depuy issued a letter to ultima tps cemented polished cobalt chromium (cocr) hip stem users in the united kingdom (uk) to inform them of a potential association between extensive peri-prosthetic soft tissue necrosis and hip stem implantation with the ultima metal-on metal (mom). following research activities undertaken by depuy, it was concluded that when used in combination with a mom articulation of an all metal type, depuy’s cemented, polished, cocr femoral hip stems, including the depuy g2 and fjord cemented femoral hip stems could potentially exhibit corrosion of the polished surfaces which are within the cement mantle. this corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. therefore, depuy advises against the implantation of the following configuration: depuy’s cemented, polished, cocr alloy femoral hip stems combined with mom articulation. according to the local supplier, ultima tps, depuy g2 and fjord cemented femoral hips stems have not been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted 03 may 2012.

Device

Cemented, Polished and Cobalt Chromium Alloy Hip Stems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: DePuy Cemented, Polished and Cobalt Chromium Alloy Hip Stems
  • Manufacturer
    DePuy

Manufacturer

DePuy