Bipolar

Main information

  • Trade name:
  • Bipolar Head - Prosthesis, internal, joint, hip, hemi
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bipolar Head - Prosthesis, internal, joint, hip, hemi
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217252
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217252

Medacta Australia Pty Ltd - Bipolar Head - Prosthesis, internal, joint, hip, hemi

ARTG entry for

Medical Device Included Class III

Sponsor

Medacta Australia Pty Ltd

Postal Address

Unit A1 / 16 Mars Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

13/11/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Medacta International SA

Strada Regina 6874 Castel

, San Pietro, 0

Switzerland

Products

1. Bipolar Head - Prosthesis, internal, joint, hip, hemi

Product Type

Single Device Product

Effective date

13/11/2013

GMDN

33704 Prosthesis, internal, joint, hip, hemi

Functional description

The Bipolar Head includes an outer shell made of stainless steel, designed to articulate directly in the

patient's acetabulum, an inner Ultra High Molecular Weight Polyethylene (UHMWPE) bearing surface, in

which articulates the prosthetic femoral head. The locking of the femoral head inside the bipolar head is

easily achieved and assured thanks to an elastic internal retaining ring.

Intended purpose

The bipolar head is designed for use in partial hip arthroplasty to provide increased patient mobility and

reduced pain by replacing the damaged hip joint, in primary or revision surgery.

Variant information

Diameter (mm) Internal Diameter: 28mm

Diameter (mm) Internal Diameter: 22mm

Diameter (mm) External Diameter: 42mm to 60mm

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 02:46:07 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

13-11-2018

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor In...

FDA - U.S. Food and Drug Administration

27-9-2018

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins. ...

FDA - U.S. Food and Drug Administration

3-5-2018

FDA Drug Safety Communication: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)

FDA Drug Safety Communication: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)

The Food and Drug Administration (FDA) is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system.

FDA - U.S. Food and Drug Administration

25-4-2018

Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction

Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction

The FDA is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels. The immun...

FDA - U.S. Food and Drug Administration

There are no news related to this product.