Events

Alerte Ou Avis De Sécurité sur Orthopaedic implant rHead Radial Head and Uni-Elbow

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Stryker.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Date
    2019-02-08
  • Date de publication de l'événement
    2019-02-08
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/orthopaedic-implant-rhead-radial-head-and-uni-elbow-risk-of-early-loosening-mda-2019-006
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
    Stryker issued a Field Safety Notice dated November 2017 informing clinicians of the recall of the rHead Radial Head and Uni-Elbow prosthesis. The manufacturer identifies the possibility of post-operative implant loosening (septic and aseptic), instability (moderate/severe), stress fracture (bone), cyst formation (bone resorption), stiffness, pain, impingement, heterotopic ossification with these devices.This Medical Device Alert is being issued to ensure that all hospitals are aware of the issue and that adequate action is taken to mitigate potential risk to patients.
  • Cause
    Manufactured by stryker – post-operative loosening of the implant which may require revision surgery.
  • Action
    Do not implant these devices (see details below) Identify and quarantine all affected devices Identify and advise all patients implanted with affected devices to contact their orthopaedic surgeon if they develop symptoms such as pain, loss of function or instability. Follow actions recommended in the manufacturer’s Field Safety Notice Report all adverse events involving this device to Stryker and through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

Device

Orthopaedic implant rHead Radial Head and Uni-Elbow
  • Modèle / numéro de série
  • Description du dispositif
    All lots of the Stryker rHead Radial Head and Uni-Elbow are affected.The manufacturer’s Field Safety Notice has details of the affected part numbers.
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Adresse du fabricant
    Stryker GmbH c/o Stryker T&E Post Market Safety Bohnackerweg 1 CH – 2545 Selzach SwitzerlandTel: +41 (0)79 904 3871tnepfa@stryker.com
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    MHRA