Events

Rappel de Ascension PyroTitan Humeral Resurfacing Arthroplasty components

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Ascension Orthopedics Inc.

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
    15219
  • Date de mise en oeuvre de l'événement
    2013-08-30
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: LMT Surgical, 9 Business Connection, 2 Kalmia Street, Ellerslie Greenlane, Auckland 1544
  • Cause
    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.
  • Action
    Manufacturer to issue advice regarding use

Device

Ascension PyroTitan Humeral Resurfacing Arthroplasty components

Manufacturer

Ascension Orthopedics Inc