Recall of Segmental System Proximal Femoral Component 38mm Offset

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Zimmer Biomet 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-2018-RN-00591-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-06
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    Zimmer biomet has received an overseas complaint regarding the segmental proximal femoral body 38mm offset alleging that the hole on the superior lateral aspect contained debris. an investigation determined that the debris was from the machining process that was not adequately removed during the subsequent cleaning process.To date, no adverse events have been reported as a result of this issue.
  • Action
    Zimmer Bioment are advising Surgeons to maintain awareness of this issue, however, there are no specific patient monitoring instructions beyond the existing follow-up schedule for patients who have been implanted with these units.

Device

  • Model / Serial
    Segmental System Proximal Femoral Component 38mm OffsetItem Number: 00585003038Multiple Lot NumbersARTG Number: 284862(Zimmer Biomet - Zimmer Segmental System, Proximal Femoral Component, 38mm offset - Uncoated femoral stem prosthesis, modular)
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA