Events

Recall of balanSys Knee System (CR, UC, PS and RP) balanSys Bone Orientated 4in1 SMaRT Instruments, balanSys BICON Knee System Template, balanSys PS Knee System Template, balanSys PE Trial Inlay 67/8-20.5, balanSys PE Trial Inlay 67/8-23, balanSys CR/PS Tibial Template 67, balanSys RP Trial Tibial Plateau 67

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-2014-RN-00094-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00094-1
  • 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
    The incorrect size determination table in surgical technique indicates that the femoral component size c is compatible with a tibial inlay/tibial plateau size 67. however, tibial components size 67 may be correctly used only with the smaller femoral components sizes a or b. the incompatible combination of the balansys cr, uc and ps systems (fixed bearing)may result in the following risks: - there is an immediate risk that the knee cannot be optimally equilibrated, which may lead to pain and instability. - in the long term, there is a risk of increased wear of the polyethylene, which may lead to pain, osteolysis, tibial loosening, instability and revision surgery. in the balansys rp system (rotating platform), there is a risk of increased soft-tissue irritation associated with pain.
  • Action
    Mathys Orthopaedics is advising surgeons and hospitals that the Surgical Technique is incorrect as it indicates that the femoral conmponent size C is compatible with a tibial inlay/tibial plateau size 67. Tibial components size 67 should only be used with smaller femoral components size A and B. A single patient was implanted with the incorrect combination in Australia. The associated surgeon has been contacted and provided with additional information for the ongoing management of the patient.

Device

balanSys Knee System (CR, UC, PS and RP) balanSys Bone Orientated 4in1 SMaRT Instruments, balanSy...
  • Model / Serial
    balanSys Knee System (CR, UC, PS and RP)balanSys Bone Orientated 4in1 SMaRT InstrumentsArticle No: 336.030.053balanSys BICON Knee System TemplateArticle # 330.030.034balanSys PS Knee System TemplateArticle # 330.030.035balanSys PE Trial Inlay 67/8-20.5 Article # 71.34.0222 - 71.34.0227balanSys PE Trial Inlay 67/8-23Article # 71.34.0263 - 71.34.0269balanSys CR/PS Tibial Template 67Article # 71.34.0538balanSys RP Trial Tibial Plateau 67Article # 71.34.0296
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd