Rappel de Prozir zirconia ceramic hip prosthesis heads

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par Saint Gobain Desmarquest Advanced Ceramics Company.

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
  • Date
    2001-08-10
  • Pays de l'événement
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
  • Notes / Alertes
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notes supplémentaires dans les données
  • Action
    The recall of a batch of Prozir zirconia ceramic hip prosthesis heads, manufactured by the Saint Gobain Desmarquest Advanced Ceramics Company, was carried out in June 2001, in agreement with Afssaps, following some 50 case of rupture of these heads .. 7 new reports of rupture of ceramic head of zirconia Prozir manufactured by the company Saint Gobain Advanced Ceramics Desmarquest on 4 different lots were brought to the attention of Afssaps .. The report of a An independent laboratory, based on the expertise of an exploded zirconia ceramic head belonging to one of these lots, reports a deterioration of the zirconia ceramic. This degradation is characterized by a porosity and a decohesion of the ceramic grains with consequent embrittlement of the implant, these defects existing before implantation. They could originate from a poorly controlled stage of the manufacturing process. The company Saint Gobain modified its manufacturing process of zirconia heads at the beginning of the year 1998. All the reported incidents relate to TH batches produced after this modification. The fractures have a priori a multifactorial origin, the elements constituting the prosthesis ( head design, cone metal nature and cone surface condition) determine its behavior during use, which could explain why not all models have experienced the same failure rate. It is not possible in the current state of knowledge to precisely identify the lots and / or models of Prozir zirconia ceramic hip prosthesis that present a risk of rupture. Considering the risks to the patient inherent to any revision of the total hip prosthesis, and pending additional information requested from the manufacturers, the director of the French Agency for the Safety of Health Products suspended the use of the heads Prozyr zirconia ceramic hip prosthesis of TH batches manufactured by the companies listed below. STRYKER HOWMEDICA OSTEONICS / BENOIST GIRARD - FII - HOSPITAL SUPPLIES INDUSTRY - LEPINE GROUP - ORTHOTECHNIC - DEPUY FRANCE - CREMASCOLI ORTHO - SULZER ORTHOPEDIA CEDIOR - BIOMET MERCK FRANCE - SEREMM - BIOTECHNI - SEM - COUSIN BIOTECH - B & JR - ALPHANORM - SANORTHO SA - SMITH & NEPHEW ORTHOPEDICS GMBH - OTI - SMITH & NEPHEW INC - DEPUY - SGM CODIM - OSTEOTOOL - FRANCE BLOC - ATF - EUROS - AMPLITUDE - EVOLUTIS - SYMBIOS ORTHOPEDIA - LAFFIT - ZIMMER - STRYKER HOWMEDICA OSTEONICS - BIOMET - DEPUY IRELAND LIMITED - DEPUY INTERNATIONAL LTD - BIOMET LTD. Each manufacturer quoted above will contact the health facilities that received these devices to identify the models / references and lots affected by this measure. alert of 16 August 200. decision of 16 August 2001

Device