Events

Recall of LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2016-RN-01191-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01191-1
  • 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
    Stryker has identified a non-conformance due to a trend analysis showing an incidence of taper lock failures higher than the predicted rate (>0.05%) for four lfit anatomic cocr v40 femoral heads manufactured prior to 2011. the increased incidence of taper lock failures relates to possible taper lock interface inconsistency. potential hazards include disassociation of femoral head from hip stem, fractured hip stem trunnion, increased metallic debris, insufficient range of motion, insufficient soft tissue tension, noise, loss of implant, bone fixation strength, increased wear debris (polymeric), implant construct with a shortened neck length.
  • Action
    Stryker is advising that patients implanted with an affected lot number of the LFIT Anatomic CoCr V40TM Femoral Heads should continue to be followed per the normal protocol established by his/her surgeon.

Device

LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures)
  • Model / Serial
    LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures)Item: 6260-9-236Head diameter 36mm; Offset +5Item: 6260-9-240Head diameter 40mm; Offset +4Item: 6260-9-244Head diameter 44mm; Offset +4Item: 6260-9-340Head diameter 40mm; Offset +8Item: 6260-9-440Head diameter 40mm; Offset +12Item: 6260-9-344Head diameter 44mm; Offset +8Item: 6260-9-444Head diameter 44mm; Offset +12Multiple lot numbers affected ARTG #: 211868
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA