Retiro De Equipo (Recall) de BIRMINGHAM HIP Resurfacing (BHR) System BHR Resurfacing Head

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 Surgical 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 (s&n;) has conducted an analysis of recent national joint registry of england and wales data. the data indicate that the revision rates associated with the female gender, and smaller femoral head sizes regardless of gender, perform less well and exceed the current revision rate benchmark established by the uk national institute for health and care excellence .S&n; is informing customers that: - the use of bhr in female patients is to be contraindicated;- bhr femoral head components sized 46mm in diameter and smaller, and their corresponding acetabular cup sizes, are no longer to be used and are to be returned to s&n; and- patients requiring a 48mm femoral head size are at a moderately elevated risk of revision and should not be considered as candidates for bhr implantation.
  • Acción
    Surgeons are advised that 48mm heads should only be used in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50mm to a measured 48mm at the time of surgery. Surgeons are recommended to maintain their routine follow-up protocol for patients who have undergone hip resurfacing arthroplasty. Patients who experience symptoms including limited mobility, pain, swelling, enlarged bursae, pseudotumors, 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 beem closed-out on 31/08/2016.


  • Modelo / Serial
    BIRMINGHAM HIP Resurfacing (BHR) System BHR Resurfacing HeadCatalogue Numbers: 74121138, 74123140, 74121142, 74123144, 74121146BHR Acetabular CupCatalogue Numbers: 74120144, 74120146, 74122146, 74122148, 74120148, 74120150, 74122150, 74122152, 74120152, 74120154BHR Dysplasia CupCatalogue Numbers: 74120246, 74122248, 74120250, 74122252, 74120254ARTG numbers: 120078 & 124099
  • Manufacturer