Events

Retiro De Equipo (Recall) de S&N Birmingham Hip Resurfacing (BHR) Dysplasia Cup

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Smith & Nephew Orthopaedics 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
    18028
  • Fecha de inicio del evento
    2015-02-05
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
  • Causa
    Smith & nephew has updated the instructions for use of the bhr system to include an expansion of the warnings for certain population sub-groups, in line with available data sources including registry data., if a patient from the following population sub-groups is implanted with a bhr system, the patient is at greater risk of requiring a revision surgery earlier than expected:, * females, * males aged 65 or greater, * patients requiring an implant head size < 48mm, patients who experience symptoms including pseudotumors, tissue masses, fluid collections, enlarges bursae, pain and swelling local buildup of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function.
  • Acción
    Instructions for use to be updated

Device

S&N Birmingham Hip Resurfacing (BHR) Dysplasia Cup
  • Modelo / Serial
    Model: 74120246, 74122248, 74120250, 74122252, 74120254, 74122256, 74120258, 74122260, 74120262, 74122264, 74120266, Affected: All lots
  • Manufacturer
    Smith & Nephew Orthopaedics Ltd

Manufacturer

Smith & Nephew Orthopaedics Ltd