Events

Rappel de Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short Neck

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Surgical Specialties 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-2017-RN-00233-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-17
  • 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-2017-RN-00233-1
  • 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
    An investigation was completed following a complaint by a surgeon that the ceramic femoral head was shorter by 2mm than other 36mm microport femoral heads. microport's investigation confirmed this complaint and concluded that the microport 36mm ceramic femoral heads have been manufactured to this specification for over 15 years. the main complaint issue associated with this finding would be surgical revision for dislocation or laxity of the hip joint.
  • Action
    Surgical Specialties is advising surgeons to maintain their usual follow-up protocol and actions for their patients and to ensure that these patients are informed about symptoms (particularly pain, instability, difficulty walking and/or performing common tasks) that indicate the need for revision surgery.

Device

Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short Neck
  • Modèle / numéro de série
    Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short NeckPart Number: 26000010 Ceramic Femoral Head 36mm SLT Taper Medium NeckPart Number: 26000011Ceramic Femoral Head 36mm SLT Taper Long NeckPart Number: 26000012
  • Manufacturer
    Surgical Specialties Pty Ltd

Manufacturer

Surgical Specialties Pty Ltd