Events

Retiro De Equipo (Recall) de Ascension PyroTitan Humeral Resurfacing Arthroplasty components

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 Ascension Orthopedics Inc.

¿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
    15219
  • Fecha de inicio del evento
    2013-08-30
  • 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: LMT Surgical, 9 Business Connection, 2 Kalmia Street, Ellerslie Greenlane, Auckland 1544
  • Causa
    The manufacturer, ascension orthopaedics, has received complaints of implant fractures that were observed post-operatively and required revision surgeries. most confirmed cases of implant breakage have occurred as a result of excessive loading and within a year of being implanted. excessive loads placed on the implant through high impact activities or sudden trauma can damage an artificial joint, particularly in the presence of poor bone stock. high impact activity may cause loosening or fracture of the implant. the breakage can result in glenohumeral joint pain and possible damage to the surrounding tissues.
  • Acción
    Manufacturer to issue advice regarding use

Device

Ascension PyroTitan Humeral Resurfacing Arthroplasty components

Manufacturer

Ascension Orthopedics Inc