Faulty hip recall: 3,500 Irish people had device fitted
Around 3,500 people in Ireland have been fitted with the metal ball and socket devices which have been found to fail early in some patients.
It is estimated that more than 400 Irish patients who had the devices fitted during hip replacement surgery may require a further operation because of problems with the parts.
DePuy Orthopaedics, a subsidiary of US pharmaceutical giant Johnson and Johnson, has recalled two products: the ASR XL Acetabular System and the ASR Hip Resurfacing System. The company has promised to pay any medical costs associated with follow-up treatment arising out of the global recall. “We are committed to assisting patients and healthcare providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures,” said David Floyd, president of DePuy Orthopaedics.
The company, which employs 650 staff at its base in Ringaskiddy, Co Cork, recalled the product after research showed one in eight patients with the implants had required further surgery within five years of being fitted with the devices.
The Irish Medicines Board said it had received reports of 12 incidents involving the ASR hip system since it was placed on the market in 2004.
A DePuy spokesperson said it ceased manufacturing both products last year as a result of falling demand and its focus on developing new, improved hip replacement devices. She also stressed the decision to withdraw the same products from Australia and the US between last December and March was not linked to current problems. However, one of the implants has been the subject of 300 complaints to the US Food and Drug Administration since 2008.
It has been confirmed that Irish hospitals no longer carry any of the affected hip implants in stock and the IMB said all devices affected by the recall have been removed from circulation.
Medical experts said those most at risk of suffering complications are people who were fitted with ASR heads below 50mm in diameter and female patients.
Anyone who received either of the products will be contacted soon to arrange a review with their orthopaedic surgeon.
Anyone suffering pain, difficulty with walking or other symptoms are also advised to contact their GP or consultant for advice.
