Events

Recall of PROFEMUR NECK VAR/VAL 8DG, Long Cobalt Chrome, Part number PHAC1254(Modular neck component of the femoral head/stem prosthesis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Wright Medical Australia 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-2015-RN-00737-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00737-1
  • 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
    Microport orthopaedics inc. has identified unanticipated postoperative implant fractures related to this specific part number. these fractures are extremely rare, yet there have been 27 reports (failure rate of 0.275%) of fracture of the phac1254 component. all fractures involve part number phac1254 (long 8-degree varus) which sees the highest bending force due to its length and therefore represents the implant in this product family with the lowest mechanical strength under clinical conditions. no implant fractures have been reported in other pro femur cocr modular neck models. in the event the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking/performing common tasks.
  • Action
    Surgeons are advised that there is no evidence fractures can be anticipated by visual inspection or during surgery. When the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking/performing common tasks. A break will require revision surgery to correct. Should a patient present with sudden pain, instability and difficulty walking/performing common tasks a postoperative fracture can be confirmed via x-ray. No additional patient follow-up is required however surgeons are advised to discuss the issues with their patients . This action has been closed-out on 04/05/2017.

Device

PROFEMUR NECK VAR/VAL 8DG, Long Cobalt Chrome, Part number PHAC1254(Modular neck component of the...
  • Model / Serial
    PROFEMUR NECK VAR/VAL 8DG, Long Cobalt Chrome, Part number PHAC1254(Modular neck component of the femoral head/stem prosthesis) All lot numbersARTG number: 234443
  • Manufacturer
    Wright Medical Australia Pty Ltd

Manufacturer

Wright Medical Australia Pty Ltd