Events

Rappel de seleXys TH+ and seleXys TPS acetabular shells (acetabular component for the joint hip prosthesis)

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-2015-RN-00770-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-14
  • 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-2015-RN-00770-1
  • 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
    Mathys orthopaedics pty. ltd. is issuing this hazard alert for its selexys th+ and tps acetabular shells used in total hip arthroplasty due to higher than expected revision rates. a detailed analysis of the aoa njrr data in april 2015 showed that the individual revision rate of selexys tps acetabular shells was 1.79 revisions per 100 component years and the revision rate of selexys th+ acetabular shells was 4.28 revisions per 100 component years. the analysis of the registry data identified a higher than expected rate of revision due to early loosening/lysis with the selexys th+ and selexys tps acetabular shell.
  • Action
    Mathys ceased supply of seleXys TH+ and seleXys TPS acetabular shells in Australia in April 2013 and June 2014, respectively. Mathys is recommending that surgeons maintain their routine follow-up protocol for patients who have undergone hip arthroplasty. The majority of additional revisions have been due to loosening/lysis, bone fracture, dislocation and pain. You may wish to consider more frequent or additional follow-up, but revision surgery should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances. For further information, please see https://www.tga.gov.au/alert/selexys-th-and-tps-acetabular-shells-used-hip-replacements . This action has been closed-out on 20/06/2016.

Device

seleXys TH+ and seleXys TPS acetabular shells (acetabular component for the joint hip prosthesis)
  • Modèle / numéro de série
    seleXys TH+ and seleXys TPS acetabular shells (acetabular component for the joint hip prosthesis)seleXys TH+ Catalogue number range: 55.42.0142 - 55.42.0164seleXys TPS Catalogue number range:: 55.40.0042 - 55.40.0064ARTG number: 122258
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd