Events

Rappel de LCS COMPLETE RPS Knee System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-00223-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-24
  • 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-00223-1
  • 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
    Jjm was recently notified by the therapeutic goods administration (tga), that the lcs complete rps knee system has a higher rate of revision than the class of ps knee systems based on recent data from the aoanjrr. after further analysis of the aoanjrr data, depuy orthopaedics, inc (the manufacturer) determined that the lcs complete rps knee system has higher rates of revision in australia when the native patella is not resurfaced when compared to other unresurfaced ps implants. the need for a second surgery to resurface the native patella is due to an increased incidence of postoperative patello-femoral pain.
  • Action
    Johnson & Johnson Medical is notifying surgeons of higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. Surgeons are advised that when using the LCS Complete RPS Knee System, the patella must be resurfaced. Johnson & Johnson Medical has also advised surgeons of the potential clinical implications for implanted LCS COMPLETE RPS Knee Systems where the native patella is not resurfaced.For further information https://www.tga.gov.au/alert/lcs-complete-rps-knee-system-used-knee-replacements. This action has been closed-out on 12/08/2016.

Device

LCS COMPLETE RPS Knee System

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes