Consumers and health professionals are advised that Smith & Nephew, in consultation with the TGA, has issued a hazard alert regarding the Birmingham Hip Resurfacing (BHR) system, advising of additional warnings when used in certain patient groups.
The BHR system is made up of multiple components and is used in hip resurfacing procedures.
The warnings have been updated in the Instructions for Use (IFU) and advise that the following groups of patients are at greater risk of requiring early revision surgery if implanted with a BHR system:
- males aged 65 or greater
- patients requiring an implant head size ≤48mm.
The additional warnings followed a statistical analysis commissioned by Smith & Nephew of data from various joint registries around the world, including the Australian Orthopaedic Association National Joint Replacement Registry.
The statistical analysis also identified two additional conditions that could contribute to increased risk of early revision:
- patients who have a diagnosis of avascular necrosis
- patients who have congenital dysplasia.
The IFU have also been updated to note that the more risk factors a patient has, the greater the risk of requiring a revision.
Pictured: BHR Resurfacing Head fitting into a BHR Acetabular Cup.