Events

Retiro De Equipo (Recall) de Birmingham Hip Product Range BHR Resurfacing Head BHR Acetabular CupCHR Dysplasia Cup BIRMINGHAM HIP Modular Head Sleeved 38MM~62MM 12/14 Modular Taper Sleeve BIRMINGHAM HIP Modular Head Monoblock 38MM~58MM

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00436-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-03
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00436-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    Smith & nephew is issuing an update to a medical device hazard alert issued in 2015 to provide surgeons and hospitals with updated information on the birmingham hip resurfacing (‘bhr’) product range and the birmingham hip modular head (bhmh) system. this update contains a current summary of the information concerning the revision rates of various products in the bhr and bhmh systems (including the monoblock version of the bhmh system).
  • Acción
    The sponsor is recommending that physicians maintain their routine follow-up protocol for patients who have undergone THA. Patients who experience symptoms including pain, swelling, enlarged bursae, pseudo-tumours, tissue masses, fluid collections, or local build-up of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function. The need for any additional follow-up, including the necessity for diagnostic imaging and blood tests, should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances. This action has been closed-out on 24/05/2017.

Device

Birmingham Hip Product Range BHR Resurfacing Head BHR Acetabular CupCHR Dysplasia Cup BIRMINGHAM ...
  • Modelo / Serial
    Birmingham Hip Product RangeBHR Resurfacing HeadBHR Acetabular CupCHR Dysplasia CupBIRMINGHAM HIP Modular Head Sleeved 38MM~62MM 12/14 Modular Taper SleeveBIRMINGHAM HIP Modular Head Monoblock 38MM~58MMMultiple Catalogue Numbers affectedAll batches affectedARTG Numbers:120078, 124099, 124100
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd