Alerte De Sécurité sur Knee Arthroplasty System / Knee Prosthesis; models: 6307-00-006 / 6307-00-008 / 6307-00-009; registration 80199020013; risk class III; lots: 61988031; 62054615; 62041152; 6,180,029; 61806575; 62005748; 61815746; 62041157; 61822616; 62005756; 62054626; 62068198; 62128274; 61831823; 61831831; 61850057; 61824682.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par MEDSINTESE Importação, exportação e comércio Eireli.; Zimmer Inc..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1812
  • Date
    2016-02-01
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    The company made a potential risk assessment and concluded that packaging adhesion is unlikely to cause an adverse effect on the patient or even the implant. As reported by the company, if wear particles generated from the film / adhesion residue of LDPE packaging were expected to elicit similar biological reactions from those of ultra high molecular weight polyethylene and are unlikely to increase the possibility of peri-prosthetic osteolysis .
  • Cause
    Some components of highly polished implants were packed in a low density polyethylene (ldpe) casing with the potential to adhere to the implants.
  • Action
    Pick up and return to the manufacturer. Action code FAM-03. The distributors must carry out the traceability of the products in their inventory. When you find products related to lots of this field action, it segregates them. The company will collect the affected units.