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Smith & Nephew issues safety notice for Birmingham Hip modular heads
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Smith & Nephew Orthopaedics AG in Switzerland has issued an update for use of its Birmingham Hip modular heads, according to a recent field safety notice.
“The indications for use of the Birmingham Hip modular heads is restricted to Birmingham Hip Resurfacing revision surgeries only where a Birmingham Hip acetabular cup is retained and is deemed not to be malpositioned or a contributor to the cause of revision,” Andy Weymann, MD, chief medical officer of the Advance Surgical Devices Division of Smith & Nephew, stated in the field safety notice. He also noted that surgeries using the Synergy uncemented femoral stem were accepted indications for using the modular head.
In the warnings part of the update, the company identified female gender, high implant abduction angle, obesity, avascular necrosis, dysplasia, component size ≤ 46 mm, and combined version (femoral neck anteversion and acetabular cup version) exceeding 45° as risk factors for revision. Contraindications included patients with infection and sepsis. Partial contraindications were patients with osteoporosis, inadequate bone stock, metabolic disorders, vascular insufficiency, neuromuscular disease and muscular atrophy, centers of infection which may spread to the surgical site, insufficient soft tissue around the joint, and metal ion sensitivity, according to the report.
Possible adverse effects to using the modular head include “inflammatory tissue response to high levels of wear debris resulting in peri-prosthetic aseptic lymphocyte dominated vasculitis associated lesions, fluid collections or soft tissue masses,” or pseudotumors, Weymann stated in the notice.
The correction in instructions for use comes from an increase in the average revision rates for the modular heads – all stems in the line now show 1.29 revisions per 100 component years in the National Joint Registry of England and Wales and 1.12 revisions per 100 component years in the Australian Orthopaedic Association’s National Joint Replacement Registry. These rates are higher than the 1% revision rate recognized by the UK National Institute for Health and Clinical Excellence.
Although the rates are higher with the modular heads alone, the report states that, “if combined with the uncemented Synergy stem, the revision rate is 1.07 revisions per 100 observed years which is acceptable and comparable to other clinically successful hip implants on the market.”
“Smith & Nephew’s highest priority is to deliver safe and effective medical technology to benefit patients. As such, we have notified customers and regulatory bodies of a change to the indications for use for the Birmingham Hip Modular Head used during total hip replacement and revision,” Andrew Burns, director of global marketing communications for Smith & Nephew, told ORTHOPEDICS TODAY.
He added, “This modification does not apply to the U.S. market where the Birmingham Hip Modular Head is not approved for use as part of a primary hip replacement procedure. This change does not apply to our BHR resurfacing device, which is performing very well, and is supported by data from several registries and independent, peer-reviewed articles. Going forward, surgeons should now use Modular Head only in conjunction with our uncemented Synergy hip stem in appropriate resurfacing revision cases. This does not change the current practice for patient follow-up care for this product.”
Reference:
http://bhmh.smith-nephew.com/downloads/FieldSafetyNotice.pdf
