Zirconia Ceramic Hip Prosthesis Heads 의 리콜

Recall

2001-08-10

France

ANSM

https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/decision-portant-sur-la-suspension-d-utilisation-de-tetes-de-prothese-de-hanche-en-ceramique-de-zircone

The Director General of the French Agency for Health Safety of Health Products. Vu. the Code of Public Health, and in particular Article L. 5312-1. Vu. the 56 reports of materovigilance incidents reporting rupture of Prozyr zirconia ceramic hip prosthesis heads from TH batches produced by Saint Gobain Desmarquest Advanced Ceramics on 5 different lots. Vu. the recall in June 2001 of Lot TH 93038 of Prozyr hip prosthesis heads produced by Saint Gobain Desmarquest Advanced Ceramics Company. Vu. the expert's report dated April 27, 2001 concerning an exploded zirconia ceramic hip prosthesis head following a rupture on a TH lot. Vu. the information provided by Saint Gobain Ceramiques Avancées Desmarquest to the French Agency for Health Safety of Health Products on July 26, 2001 informing it that it was planning to start a research program using its production tool. Vu. the mail of the French Agency for the Safety of Health Products to the various manufacturers concerned on 2 August 2001. Recital. that the report of the independent laboratory following the expertise of an exploded TH batch zirconia ceramic hip prosthesis head indicates a deterioration of the zirconia ceramic in the form of a porosity and a decohesion of the ceramic grains causing embrittlement of the implant, defects existing before implantation. Considering. that the fractures are a priori of multifactorial origins, the elements constituting the prosthesis, design of the head, nature of the metal of the cone, state of surface of the cone, determining its behavior during the use. Considering. that it is not possible in the current state of knowledge to precisely identify batches and / or models of zirconia ceramic hip prosthesis presenting a risk of rupture. Considering. that there exist, alternative solutions to the laying of Prozyr zirconia ceramic hip prosthesis heads of lots TH. Considering. the increased risks for the patient inherent to any revision of the total hip prosthesis, and in particular the vital risk related to any surgical procedure, the risk of femoral fracture and the risk of intraoperative hemorrhage, the risks of infection and postoperative thrombotic agravity, the risk of hip dislocation and therefore the risk of walking. Considering. that the French Agency for the Safety of Health Products has requested additional information from each manufacturer concerned, and that, pending these elements, it is necessary to suspend the use of hip prosthesis heads TH batch zirconia ceramic manufactured by Saint Gobain Advanced Ceramics Desmarques. Decided. Article 1. - The use of TH batch zirconia ceramic hip prosthesis heads manufactured by the company Saint Gobain Advanced Ceramics Desmarquest and marketed by companies. 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 LT. is suspended from the date of publication of this Decision. Article. - The Director of the Evaluation of Medical Devices and the Director of Inspection and Institutions are responsible, each for his own part, for the execution of this decision, which will be published in the Official Journal of the French Republic. Dated at Saint-Denis, August 10, 2001