Events

Recall of Intramedullary (SP 2 IM) Rod 400mm Instrument (surgical instrument used in both primary and revision P.F.C. SIGMA knee procedures)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-00956-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00956-1
  • 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
    Complaints have been received that the rod fractured and a portion of the rod was left in the patient. all of the complaints involved the sp2 im rod 400mm instrument made with 455 ss alloy. there is a deep j-shaped groove at the tip of the rod, which allows a sleeve to lock into place when used in revision cases. it is within this groove that fracture can occur. if the affected sp2 im rod 400mm instrument fractures during surgery and a portion of the rod is left in the patient, the possible clinical implications are: if observed during surgery:- significant surgical delay due to attempted retrieval of remaining rod- minor bone damage due to attempted retrieval of remaining rodif not observed during surgery:- adverse tissue reaction may occur because the fractured rod, if not removed from within the bone, can act as a stress riser causing remodelling of bone and inflammation- pain due to potential bone remodelling or during magnetic resonance imaging (mri).
  • Action
    DePuy will be providing users with swap-out instruments as soon as possible to minimise any surgical disruption. In the meantime, medical professionals may opt to use the other size of the SP2 IM Rod: 300mm SP2 IM ROD (PN 96-6121). If a surgeon performed a procedure with an affected instrument and experienced a fractured instrument, the company recommends that surgeon users discuss potential clinical implications and risks with symptomatic patients. This action has been closed-out on 06/09/2016.

Device

Intramedullary (SP 2 IM) Rod 400mm Instrument (surgical instrument used in both primary and revis...
  • Model / Serial
    Intramedullary (SP 2 IM) Rod 400mm Instrument (surgical instrument used in both primary and revision P.F.C. SIGMA knee procedures)PN 96-6120Dates manufactured:4 April 1995 - 22 June 2001 (Material 17-4-SS)27 August 2008 to 2 October 2012 (Material 455 SS)Kits containing SP2 IM Rod 400mm Instruments (PN 96-6120) include:ZZINAUK001 ZZINAUK0605 ZZINAUK9054 (WA ONLY)ZZINAUK9079 (WA ONLY)ZZINAUK9094 (WA ONLY)ARTG Number: 132151
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes