Events

Recall of balanSys RP Tibial Plateau TiNbN cem

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mathys Orthopaedics 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-2017-RN-00962-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00962-1
  • 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
    Mathys has received several reports about soft tissue reactions due to the wear of particles of unknown origin detected during a revision of surgereies of balansys rp tinbn total knee protheses in patients that are suffering persisting pain and synovitis. this debris can cause infections leading to soft tissue damage which may compromise the result of the total knee arthroplasty.Patients who experience symptoms including limited mobility, pain, swelling, etc. may need to contact their treating physician. the need for any additional follow-up, mri or ultrasound scans, arthroscopy or revision surgery should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances.
  • Action
    This action has been closed-out on 09/08/2017.

Device

balanSys RP Tibial Plateau TiNbN cem
  • Model / Serial
    balanSys RP Tibial Plateau TiNbN cemItem Numbers: 72.34.0155, 72.34.0156, 72.34.0157, 72.34.0158, 72.34.0159, 72.34.0160, 72.34.0161, 72.34.0162Reference Number: FSCA 17/03ARTG Number: 211086
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd