Events

Safety Alert for ABGII Modular Femoral Stem and Modular Neck

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

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
    2012-07-23
  • Event Date Posted
    2012-07-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120723.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: stryker australia pty ltd abgii modular femoral stem and modular neck the therapeutic goods administration (tga), australia issued a medical device safety alert concerning abgii modular femoral stem and modular neck manufactured by stryker australia pty ltd. according to the manufacturer, there is potential for fretting and corrosion at the join between the femoral stem and the neck component of the abgii modular system. fretting and corrosion can result in metal debris in and around the hip joint. if this occurs, patients may experience inflammation, adverse local tissue reactions (altrs), hypersensitivity/allergic reactions and osteolysis (bone loss). stryker australia pty ltd has contacted every australian orthopaedic surgeon who has ever implanted the abgii modular hip replacement system. those surgeons have been asked to contact their patients to discuss what clinical action is most appropriate. if the results reveal that adverse local tissue reaction of patients are due to metal wear debris, the surgeon should consider proceeding with a revision of the femoral component to a monolithic stem. the manufacturer also advised patients that if experiencing hip or thigh pain, or are concerned about the hip replacement, they should contact their implanting surgeon to arrange a review appointment. for details, please refer to tga website http://www.Tga.Gov.Au/safety/alerts-device-abgii-120720.Htm. posted on 23 july 2012.

Device

ABGII Modular Femoral Stem and Modular Neck
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Stryker Australia Pty Ltd ABGII Modular Femoral Stem and Modular Neck
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DH