Events

Recall of SMF and MDF Modular Neck Hip Prosthesis Multiple products affected

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Pty Ltd.

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
    RC-2016-RN-01649-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01649-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    During a recent review of product complaints received by smith & nephew and clinical study data associated with the modular hip prostheses, a rate of complaints higher than comparable monolithic hip prostheses was observed.Metal-related complaints are trending upward year-on-year with an overall complaint rate (number of complaints/total implantations) of 0.527% for modular smf and 0.25% for modular redapt revision femoral hip systems. overall, the metal-related adverse events accounted for the highest category of complaints in both products.
  • Action
    Smith & Nephew is advising physicians to maintain their routine follow-up protocol for patients who have undergone total hip arthroplasty and continue to monitor for pain, swelling, limited mobility and enlarged bursa. For symptomatic patients, physicians may consider additional clinical follow-up. The need for any additional follow-up should be determined on an individual case-by-case basis following an assessment of patients’ clinical circumstances. Follow-up examinations should be repeated for symptomatic patients annually for the lifetime of the device to potentially help reduce the risk of complication and the need for additional surgery.

Device

SMF and MDF Modular Neck Hip Prosthesis Multiple products affected
  • Model / Serial
    SMF and MDF Modular Neck Hip Prosthesis Multiple products affectedPrevious ARTG Number: 101100
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd