Alerta De Seguridad para MITCH TRH acetabular cups/MITCH TRH modular heads (Finsbury Orthopaedics) implanted with uncemented Accolade femoral stems (Stryker Orthopaedics)

Safety alert

2012-04-03

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120403.html

Mhra issued new advice about metal-on-metal total hip replacements: mitch trh acetabular cups/mitch trh modular heads (finsbury orthopaedics) implanted with uncemented accolade femoral stems (stryker orthopaedics) the united kingdom (uk) medicines and healthcare products regulatory agency (mhra) issued advice to orthopaedic surgeons to stop implanting mitch trh acetabular cups/mitch trh modular heads in combination with uncemented accolade femoral stems. it is because this particular combination has a high revision rate (10.7%) compared to other types of hip implant. the mhra also provided follow-up recommendations to patients with this combination of implant. the mitch trh system is a metal-on-metal hip replacement system consisting of components that can be used in different combinations to carry out either hip resurfacing arthroplasty or total hip replacement. the system was manufactured by finsbury orthopaedics and was distributed in the uk by stryker orthopaedics between may 2006 and october 2011. analysis of data from the england and wales national joint registry (njr) up to 10 march 2012 has shown that the cumulative revision rate for mitch trh system total hip replacements (revision rate of 8.8% at 4 years based on 445 patients recorded by the njr) is higher than indicated as acceptable by the national institute for health and clinical excellence. further analysis of njr data has now determined that the cumulative revision rate of mitch trh system total hip replacements varies considerably depending upon which femoral stem is used: mitch trh with exeter v40 – revision rate of 3.7% at 4 years based on 120 patients recorded by the njr mitch trh with uncemented accolade – revision rate of 10.7% at 4 years based on 271 patients recorded by the njr mitch trh with abg ii - rate of usage too low to estimate revision rate in view of the high revision rate when mitch trh acetabular cups/mitch trh modular heads is used in combination with uncemented accolade femoral stems, mhra advised orthopaedic surgeons to stop using this combination and provided advice on appropriate follow-up recommendations for patients with this combination of implant. according to the local supplier, this particular combination has not been distributed in hong kong. for details regarding the mhra’s latest management recommendations, please visit: http://www.Mhra.Gov.Uk/publications/safetywarnings/ medicaldevicealerts/con149600 http://www.Mhra.Gov.Uk/newscentre/pressreleases/con149601.