Events

Recall of PROFEMUR HIP SYSTEM - NECK VAR/VAL 8DG LONG COBALT CHROME

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MICROPORT ORTHOPEDICS 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
    19944
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Microport orthopedics inc. is voluntarily recalling profemur long cobalt chrome 8 degree varus/valgus modular neck part number phac1254. this product is used with modular hip stems during total hip arthroplasty surgery. microport orthopedics inc. has received reports of an unexpected rate of postoperative fractures related to this specific part number. all lot numbers may be affected. further distribution or use should cease immediately. 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. it is expected the patient will recognize immediately that the device is not functioning properly and seek medical attention. a fracture will require revision surgery to remove and replace the neck and stem components.

Device

PROFEMUR HIP SYSTEM - NECK VAR/VAL 8DG LONG COBALT CHROME
  • Model / Serial
    Model Catalog: PHAC1254 (Lot serial: > 10 contact manufacturer)
  • Product Description
    PROFEMUR Neck VAR/VAL 8DG Long Cobalt Chrome Neck
  • Manufacturer
    MICROPORT ORTHOPEDICS LTD

Manufacturer

MICROPORT ORTHOPEDICS LTD