Events

Rappel de Device Recall NaturalKnee II Durasul AllPoly Patella, Size 0, 7mm

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Zimmer 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
    60858
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0848-2012
  • Date de mise en oeuvre de l'événement
    2011-12-21
  • Date de publication de l'événement
    2012-01-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106653
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). the failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. analysis shows that the highly cross-linked polyethylene, durasul, patella was shown to have a lower fracture fatigue strength than the sulene counterpart and that the cement technique used.
  • Action
    Zimmer sent an Urgent Device Recall letter dated December 20, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop distribution of the affected product and return all lots in inventory. Customers should provide a list of all hospitals and surgeons that have used the affected product by completing the User Facility and Health Care Professional Form and fax a copy to (574) 372-4265. If customers distributed the product further they should provide a copy of the recall letter to those customers. For questions regarding this recall call 1-877-946-2761.

Device

Device Recall NaturalKnee II Durasul AllPoly Patella, Size 0, 7mm
  • Modèle / numéro de série
    6301-07-100; all lots
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Belgium, Germany, France, Austria, Sweden, Switzerland, South Africa, and the UK
  • Description du dispositif
    Natural-Knee II Durasul All-Poly Patella, Size 0, 7mm || The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Adresse du fabricant
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA