Events

Rappel de SMF and MDF Modular Neck Hip Prosthesis Multiple products affected

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smith & Nephew 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-2016-RN-01649-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-22
  • 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-2016-RN-01649-1
  • 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
    During a recent review of product complaints received by smith & nephew and clinical study data associated with the modular hip prostheses, a rate of complaints higher than comparable monolithic hip prostheses was observed.Metal-related complaints are trending upward year-on-year with an overall complaint rate (number of complaints/total implantations) of 0.527% for modular smf and 0.25% for modular redapt revision femoral hip systems. overall, the metal-related adverse events accounted for the highest category of complaints in both products.
  • Action
    Smith & Nephew is advising physicians to maintain their routine follow-up protocol for patients who have undergone total hip arthroplasty and continue to monitor for pain, swelling, limited mobility and enlarged bursa. For symptomatic patients, physicians may consider additional clinical follow-up. The need for any additional follow-up should be determined on an individual case-by-case basis following an assessment of patients’ clinical circumstances. Follow-up examinations should be repeated for symptomatic patients annually for the lifetime of the device to potentially help reduce the risk of complication and the need for additional surgery.

Device

SMF and MDF Modular Neck Hip Prosthesis Multiple products affected
  • Modèle / numéro de série
    SMF and MDF Modular Neck Hip Prosthesis Multiple products affectedPrevious ARTG Number: 101100
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd