A new medical device alert has been issued for Smith & Nephew Orthopaedics Birmingham Hip Resurfacing (BHR) system due to a higher than expected failure rate, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency said. The notification, posted on the regulators’ website on June 25th, said that the metal hip device should not be implanted in certain groups of patients, including women or patients who need a femoral head sized 46 mm or less, due to a high failure rate.
The notification also states to “Only use 48mm BHR heads in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50mm to a measured 48mm at the time of surgery”.
In metal-on-metal hip implants, all surfaces are made of metal. These devices were first marketed as being more durable and better suited for younger, more active patients but their safety has come into question following high-profile recalls and thousands of lawsuits.
The implants can release metal particles and cause complications when metal surfaces grind together. The devices have been associated with a high rate of early failure, prompting patients to undergo a revision surgery much earlier than anticipated.
Customers should return all devices that have femoral head sizes 46 mm
Customers should return all devices that have femoral head sizes 46 mm and smaller and their respective acetabular and dysplasia cups, the alert said. The notification affects patients who are symptomatic, female, or patients with head sizes 46 mm or smaller.
These groups of patients were identified by Smith & Nephew using recent data from the National Joint Registry (NJR) for England, Wales and Northern Ireland to identify these groups of high-risk patients. The device alert also gave recommendations for affected patients, including the need for blood metal ion testing.