Events

Rappel de 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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Mathys Orthopaedics Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00094-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-31
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00094-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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...
  • Modèle / numéro de série
    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