The Medicines Agency has identified new marketing offenses for CERAVER’s devices.
After the non-compliant hip prostheses, then the knee prostheses, this time, it is on the orthopedic implants that the company Ceraver is pinned. The Medicines Safety Agency (Ansm) announces that it has identified new offenses related to the marketing of these implantable devices without having a CE marking certificate. These non-conformities were observed on acetabular cups, transient tibial bases and titanium lattices.
However, the Agency wishes to reassure any people carrying these devices and indicates (as in previous episodes) that they have “no element leading to suspect a health risk specific to these devices”. Nevertheless, insofar as these infringements were materialized, the Ansm took on July 11, 2013 a new decision health policy providing in particular, “the suspension of the marketing, commissioning, export, distribution and use of the medical devices concerned, until compliance”, but also , “The withdrawal of the medical devices concerned from any place where they are”.
In addition, as a precautionary measure, the Agency in agreement with the French society of orthopedic surgery (SOFCOT) recommends “to orthopedic surgeons who have placed the implants (…) to review their patients in order to inform them, and to mention the use of these devices in their medical file and assess their clinical and radiological condition ”. Finally, the Ansm also recommends that these surgeons offer their patient “individualized follow-up (clinical and radiological evaluation at 6 months and 1 year regardless of the duration of the implantation), then in the absence of complications, to come back. on a usual follow-up of patients with this type of orthopedic implants ”.
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