Events

Recall of Tandem Bipolar Hip System (hemiarthroplasty hip prosthesis)

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-01167-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01167-1
  • 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
    Smith & nephew have identified a manufacturing error which affects certain batches. the affected devices were manufactured with a retainer groove that is out-of-specification. the out of specification condition could potentially result in one of three functional failures: the device will not assemble, the head is too tight or in rare occasions, the device may appear to be assembled properly during surgery but later disassociate post-operatively. the likelihood of implant detachment after surgery is very low. however, if it did occur, it would happen within the first few weeks after the operation and be clearly recognised by the patient (and confirmed by x-ray).
  • Action
    Smith & Nephew is advising users that there is no recommendation for proactive revisions. Failure of the device will result in the patient experiencing pain, limited mobility or loss of range-of-motion. Surgeons should maintain their routine follow-up protocol for patients who have been implanted with a potentially affected device. Smith & Nephew is advising users to inspect stock and quarantine the affected devices for return. Affected devices can be returned for credit or replaced with unaffected product. This action has been closed-out on 24/05/2017.

Device

Tandem Bipolar Hip System (hemiarthroplasty hip prosthesis)
  • Model / Serial
    Tandem Bipolar Hip System (hemiarthroplasty hip prosthesis)Material Numbers: 71324041, 71324044, 71324045, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, Multiple Batch Numbers affectedARTG Number: 242993
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd