Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision
Manufactured by Biomet – risk of revision surgery from an increase in bone cement polymerisation time and reduced mechanical strength.
"Correspondence with the MHRA and the Secretary of State related to cobalt-chrome alloy implants"
Given on the parliament.uk website.
Introductory Guide to new medical device regulations launched
MHRA Press Release. The interactive guide will help new and experienced manufacturers navigate their obligations under new EU regulations on medical devices.
Manufactured by Zimmer Biomet – do not use this device in the reverse configuration. (MDA/2017/023). MHRA.
All metal-on-metal (MoM) hip replacements: updated advice for follow-up of patients
MHRA is updating advice provided in MDA/2012/036, to assist the early detection of soft tissue reactions in patients implanted with metal-on-metal (MoM) hip replacements (MDA/2017/018).
Anyone can report a problem with a medicine or a medical device via the MHRA Yellow Card Scheme.
Reporting suspected side effects makes medicine safer.
From MHRA "Regulatory guidance for medical devices"
Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.
MHRA: (Smith & Nephew Orthopaedics) Birmingham Hip™ Resurfacing (BHR) system - higher than expected revision rate for certain patient groups.
MHRA "Field safety notice (FSN): what it is and why it's important"
This document is a flyer that is circulated to organisations alongside a field safety notice covering what it is and why it's important to take action. A ‘field safety notice’ (FSN) is an important communication about the safety of a medical device that is sent to organisations by a device manufacturer, or their representative. FSNs tell the organisation what they need to do to reduce the specified risks of using the medical device. The actions are referred to as ‘field safety corrective actions’ (FSCAs).
DePuy Orthopaedics, Inc. is voluntarily issuing a Field Safety Notice (FSN) for all lots of the LCS® COMPLETE™ RPS Knee System (See Attachment A). The FSN is being issued due to the potential occurrence of pain when the native patella is not resurfaced, as reported in the Australian Registry. When using the LCS Complete RPS Knee System, the patella must be resurfaced. Failure to resurface the patella has been associated with a higher incidence of postoperative patello-femoral pain potentially leading to a secondary procedure.
MHRA: Medical devices: conformity assessment and the CE mark
How to conform with the legal requirements for placing medical devices on the market.
MHRA: Medical devices: guidance for manufacturers on vigilance
Information for manufacturers of medical devices about reporting adverse incidents and corrective actions to MHRA.
MHRA: Reporting adverse incidents: joint replacement implants
There is now device-specific guidance for manufacturers reporting adverse incidents with joint replacement implants under the European vigilance system.
Medical device alert from MHRA: Risk of early wear of the ultra high molecular weight polyethylene (UHMWPE) plastic part of the tibial plateau of this device.
MHRA and NHS England in initiative to simplify adverse incident reporting
MHRA and NHS England have jointly issued two patient safety alerts and supporting guidance to help simplify reporting and help healthcare providers increase incident reporting involving medication errors and medical devices.
Stephenson report into devices engagement with clinical community published
MHRA report, April 2014, mentions metal-on-metal hips.
made as part of the BMJ "Out of Joint" feature
MHRA’s Safety warning about metal-on-metal hip replacements
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK body which oversees the safety of medicines and medical devices.