X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 018 04 12 000
Date submitted: 4/3/2012
Manufacturer:DePuy International Limited
Device Type:Hip implant, Mitch TRH Acetabular Cup / Mitch TRH
Description:Hip implant
Medical Device Identifier:Mitch TRH Acetabular Cup / Mitch TRH Modular Head (Finsbury Orthopaedics Ltd) when implanted with the uncemented Accolade femoral stem (Stryker). The system was manufactured by Finsbury Orthopaedics and was distributed in the UK by Stryker Orthopaedics between May 2006 and October 2011.
Reason of Field Safety Corrective Action: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 used in hip resurfacing arthroplasty (revision rate of 3.1 % at 4 years based on 769 patients recorded by the NJR) is in line with relevant guidance from the National Institute for Health and Clinical Excellence (NICE) guidance,1,2 but 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 NICE.
Remedy Action:Do not implant MITCH TRH acetabular cups/MITCH TRH modular heads in combination with uncemented Accolade femoral stems.
Athorized Representative/Importer/Distributor:Johnson & Johnson Medical Meddile East, Riyadh, (01) 4603292
Report Source:NCAR
Source Ref. Number:UK-2012-04-02-061
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments