DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2007/054

CON2031467

2007-06-14

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2031467

Unexplained groin pain. the need for early revision due to periprosthetic soft tissue necrosis. the ultima tps femoral stem and ultima metal-on-metal articulation (femoral head plus metal acetabular cup) is a total hip replacement system that has been on the market in the uk since 1997. the ultima tps femoral stem is still available but the ultima metal-on-metal femoral head and acetabular cup were discontinued in 2005. up to april 2007, one uk study has reported 43 revisions (from a cohort of 637 hips) associated with extensive periprosthetic soft tissue necrosis. some also involved late dislocation or periprosthetic fracture. the revisions were required one to seven years after implantation. there have been no other confirmed reports. when these stems were explanted, extensive corrosion was observed on the surface of many of them within the area of the cement mantle. this level of corrosion of cemented polished cobalt chromium molybdenum stems has not previously been reported in the orthopaedic literature and the explanation for it is unclear. depuy has already communicated this information to uk hospitals that implanted these devices. a copy of their letter, including recommendations for imaging and patient management, is in the appendix.

Refer patients with this implant combination who present with unexplained groin pain for MRI scan. This is in line with the parameters recommended by DePuy (see recommendations for patient management under ‘Action’ in the appendix). Patients with abnormal signs should be considered for an early revision. Report all revisions of metal-on-metal articulations where corrosion and/or periprosthetic soft tissue reaction are observed to the implant manufacturer and the MHRA.