Notificaciones De Seguridad De Campo acerca de Triathlon PKR Unicondylar Femoral Component Cemented – Implant, Scorpio Waffle Total Stabilized Femoral Component Tip: Left; Right– Implant, Scorpio femoral Component without LFIT and with Pegs Tip: CR Left; CR Right; PS Left; PS Right– Implant

Field Safety Notice

2014-05-09

2014-06-10

Serbia

ALIMSA

https://www.alims.gov.rs/latin/2014/10/06/obavestenje-o-meri-povlacenja-sa-trzista-medicinskih-sredstava-2/

During the quality control process, the manufacturer noted, for certain lots of "triathlon" femoral and "scorpio" femoral components and restorative wedge enhancers, the incompatibility of the inner packaging with the requirements. specifically, it was found that the force required to open the inner package was less than the force prescribed by internal, validated requirements. the long-term shelf life of a sterile barrier is conditioned by the way the primary packaging is welded, that is, the stability of the sterile barrier depends on the strength with which the packaging is welded. during the quality control process, it was confirmed that the outer packaging of these medical devices was complete or undamaged. by investigation, the manufacturer has determined that the cause of the problem lies in production. the vacuum pressure of the equipment was found to be low because there was a fault on the pressure gauge as well as on the valve. by adjusting the control valve, the cause of the problem has been eliminated. possible patient complications that occur when a sterile barrier is broken are an infection that requires additional medical intervention, as well as delaying surgery if the healthcare provider notices that the packaging is poorly welded, doubts the sterility of the product, and decides to purchase another implantable medical device .