25 June 2012
The Medicines & Healthcare products Regulatory Agency (MHRA) has today issued advice to surgeons following a voluntary product recall by manufacturer Smith & Nephew. The advice given to surgeons is to stop using a particular type of metal cup liner that is used in some
metal-on-metal hip replacement operations.
The recall by Smith & Nephew concerns the R3 metal cup liner component of the R3 Acetabular System, which is used with the femoral components. The problem outlined in the Device Alert states that there are “increased rates of revision of metal-on-metal hip replacements when using the metal liner component of the R3 acetabular system. Post market surveillance is reported to show data indicating a revision rate of 6.3% at four years, for patients implanted with the R3 metal liner.".
The MHRA reported that: “the high revision rate is not in line with the 4% guidance figure at four years from the National Institute of Health and Clinical Excellence and therefore the MHRA has told surgeons to stop using the metal cup liners and to annually monitor the 281 patients who have been fitted with these cup liners so that any complications such as pain or swelling are picked up and treated early.”
These concerns continue to add to the negative press surrounding the difficulties caused by metal-on-metal hip prostheses. The MHRA also issued updated advice today in relation to the monitoring of hip resurfacing systems and stemmed metal-on-metal total hip replacements, with a femoral head diameter of less than 36mm. The updated advice aimed at clinicians, seeks the implementation of updated systems for follow up and investigation of patients implanted with these metal-on-metal hip components.
The advice given in this most recent MHRA alert, reflects monitoring systems implemented in February 2012 relating to metal-on-metal prostheses sized 36mm or more. It was in February 2012 that the MHRA sought monitoring on an annual basis rather than the previous five year monitoring system in place. The purpose of the updated advice today also mirrors previous observations made by the MHRA; that clinicians take the view early revision of poorly performing metal-on-metal should give a better revision outcome. Specific recommendations are outlined by the MHRA in today’s alert.
Continued monitoring of metal on metal hip implants is reported to be a focus of the MHRA, with an expert advisory group reported to have been set up in early 2012. The group is said to meet up regularly to consider clinician observations, scientific advice and the management of patients with soft tissue swellings, associated with metal-on-metal hip devices.
The MHRA report that they are “continuing to monitor the situation in consultation with orthopaedic experts and may issue further advice.”
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