Alerta De Seguridad O Notificaciones De Seguridad para VKS, RT-Plus and TC-Plus femoral and tibial knee components

Safety alert / Field Safety Notice

MDA/2008/003

CON2033730

2008-01-16

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2033730

Extension of recall of implants which may have incorrect alloy composition. as a result of a manufacturing error, some knee implant components have been made from an alloy of incorrect composition. in november 2007, the manufacturer recalled some affected products and provided the mhra with a list of uk affected products (see appendix (in pdf only) - rows in grey). the mhra issued mda/2007/092 relating to this recall, on 4 december 2007. the manufacturer extended the recall in december 2007 (see appendix (in pdf only) for full list of uk affected products). 520 affected products have been distributed to uk hospitals since june 2007. the clinical implications for patients implanted with affected products are currently being assessed. the manufacturer’s initial risk assessment is that there is no indication of any health risk to patients as a result of the higher iron content in these devices. the manufacturer is, however, carrying out further tests in order to fully assess the situation. the mhra will issue further advice on patient management when this assessment has been completed.

Do not implant affected products (lot numbers listed in Appendix). Quarantine all affected products and return them to the manufacturer. Report revisions or adverse incidents related to affected products to the MHRA.