Birmingham, Corin, Food & Drug Administration, Hip Replacement, Metal on metal hip, Metal-on-Metal components, Michael King, Patient, Smith & Nephew, Smith & Nephew Hip Recall, United Kingdom Hip Recall, UNited States
S&N recalls hip replacement parts
By Karen Attwood Friday, 17 August 2007: This Article from the Independent [Click here]..
The hip and knee maker Smith & Nephew has had to recall more than 185 hip implants after incorrect labelling meant at least two patients were given the wrong-sized hip device.
The patients are having to undergo a further operation in order to get the right-sized device fitted after different sizes of a part of the company’s recently launched Birmingham Hip Resurfacing System were mixed up during the packaging process.
The error occurred at a sub-contractor to Smith & Nephew and when discovered the company immediately voluntarily withdrew the implants, which it said were manufactured in a small number of batches. S&N also notified the Medicines & Healthcare Products Regulatory Agency and the US Food & Drug Administration. The devices were distributed to a number of countries including to the United States.
Patients who are suspected of having the wrong-sized device can be X-rayed to ascertain whether the hip is “wobbly”, a spokesman said. If hips are not the perfect fit, they wear out more quickly, he added.
The Birmingham hip was the first of a new kind of less-invasive hip implant to be approved by regulators in the US.
“Smith & Nephew are working closely with patients and surgeons to ensure that appropriate and immediate follow-up takes place,” the company said. “Quality standards are an integral part of the way Smith & Nephew does business and we continue to vigorously pursue and enforce these standards.”
Distribution of the product continues as normal and is meeting demand, it added.
Michael King, an analyst at Nomura Code, said the timing of the recall was unfortunate as its rival Corin was in the process of launching a competing product, which recently won US approval.
“Although this is an error by a subcontractor, it is not good news for S&N as they will have to pay for the removal and any damages that may follow,” he said.
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