Events

Rappel de balanSys RP Tibial Plateau TiNbN cem

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-2017-RN-00962-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-09
  • 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-00962-1
  • 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 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
  • Modèle / numéro de série
    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