Medical device maker, Smith & Nephew, just issued a safety alert for its components in its Birmingham hip implant line, following emergent data on the their failure rate.
The safety alert, does not, pointed out Becker’s Spine Review, include a device recall; however, the device’s failure rate does exceed the U.K.’s National Institute for Health and Clinical Excellence’s benchmark of one percent. Smith & Nephew’s Birmingham Hip Modular Head implants are part of a collection of the manufacturer’s devices that led the way for the metal-on-metal hip implant field in 1997.
In its notice, Smith & Nephew updated indications for its Birmingham Hip Modular Head implants following data from U.K. and Australian registries which revealed a 1.29 percent (U.K.) and 1.12 (Australian Orthopaedic Association’s National Joint Replacement Registry) percent failure rate, said Becker’s Spine Review. The updated indications restrict the device to its Synergy stems and during revision surgeries, in which cases the failure rate drops to 1.07 percent, which is considered acceptable, according to a report issued by MassDevice.com, said Becker’s Spine Review.
Smith & Nephew spokesman, Joe Metzger, told Mass.Device.com, “…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. The potential risks that may result from use of the device have not changed.”
“They may include pain and limited mobility, potentially leading to revision surgery. Females of child=bearing age are at greater risk with metal-on-metal implants. Severely overweight individuals have been observed to be at greater risk of revision surgery,” Metzger also noted. “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,” Metzger told MassDevice.com.
The alert, which did not go as far as to recall the device, is still a blow to industry, which has been mired in controversy, lawsuits, recalls, and growing injury reports and involves a number of device makers, including Johnson & Johnson’s DePuy Orthopaedics’ unit, Biomet, Zimmer, and Wright Medical.
NewsInferno explained that introduction of the Birmingham hip replacement line prompted other device makers to bring metal-on-metal hip devices to market. This summer, MassDevice.com reported that Smith & Nephew rival, Wright Medical Inc., challenged the company’s 2006 application for U.S. Food & Drug Administration (FDA) approval of the Birmingham. The claims included that the study used in Smith & Nephew’s application was insufficient in the areas of safety and efficacy. The FDA did grant two pre-market approvals for the Birmingham in May and October 2006; the latter approval involved additional sizes.
Metal-on-Metal hip implant devices have been blamed for shedding dangerous amounts of metal debris in patients, leading to premature implant failure, adverse local tissue reactions, metallosis, pseudotumor formation, and a host of other long-term health problems.