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premature failures 6 articles

Surgeon: Metal hip implant failures led to ‘severe patient wreckage’

“I’d seen patients coming into the clinic complaining of groin pain. I saw it once and then again and then again and again,” Surgeon Antoni Nargol told Four Corners, an investigative news program for ABC News Australia. Nargol was referring to patients who had received ASR metal-on-metal hip replacement systems made by Johnson & Johnson subsidiary DePuy Orthopaedics. The devices were recalled in 2010 after mounting reports of premature failures and infections caused by heavy metal blood poisoning. New research shows that Johnson & Johnson knew the devices were defectively designed as early as 2006 – four years before the ... Read More

Family says defective metal-on-metal hip implant caused mother’s brain cancer

A woman who had filed a lawsuit against Johnson & Johnson for its defective metal-on-metal hip implant has died of an aggressive brain cancer, a disease her family believes was caused by blood poisoning from her corroding artificial hip. Bharucha had broken a hip when she suffered a fall and in 2007 was fitted with Johnson & Johnson’s DePuy ASR hip replacement system. The surgery did not relieve her pain or help her regain her mobility. In fact, she grew increasingly worse. By 2011, a year after the device was recalled due to premature failures, Bharucha had revision surgery to ... Read More

Spanish king undergoes third hip replacement surgery due to joint infection

King Juan Carlos of Spain, 75, underwent a third hip replacement surgery less than two years after the last hip treatment, because the tissue surrounding the implant had become infected.  Carlos has undergone seven surgeries since 2010, including having both his hips replaced during three surgeries last year. The first hip replacement surgery came after he fell during an elephant-hunting holiday in Botswana. The monarch never gained full mobility after his last hip surgery and requires a cane to walk. It is not reported what type of artificial hip Carlos received. Traditional hip implants are made with ceramic or plastic ... Read More

FDA launches tracking, monitoring program for high-risk medical devices

The Food and Drug Administration (FDA) is launching a new program that requires manufacturers of medical devices to put codes on their products so that the agency can track the devices, monitor their safety, and issue recalls when problems arise. The codes, known as unique device identifier, or UDI codes, placed on each medical device from defibrillators to artificial joints, will be entered into a public, searchable database. The UDI codes must also be noted in medical device records. The first devices to receive the UDI codes will be higher risk devices, including heart pumps and artificial hips. Many low-risk ... Read More

DePuy engineers knew of problems with metal hip implant but decided not to warn surgeons

An engineer with medical device maker DePuy Orthopaedics, a subsidiary of Johnson & Johnson, warned executives in 2008 that its ASR metal-on-metal hip replacement system is susceptible to releasing extreme metal ions into the bloodstream of patients who had the devices implanted in their bodies, and said that the company needed “to discuss this at the earliest possible opportunity as I believe it means that we need to start any ASR upgrade sooner than our previous plans had suggested.” The DePuy engineer who warned colleagues was Graham Isaac and, despite a memo documenting his concerns about the ASR, Isaac said ... Read More

Plagued by recalls, lawsuits, Johnson and Johnson lowers profit forecast for year

Plagued by recalls and lawsuits from consumers and shareholders, health care products giant Johnson & Johnson lowered its profit forecast for the year. The change was made after the company posted second-quarter net income that had dropped by half. Johnson & Johnson reported net income of $1.41 billion – or 50 cents a share – down from $2.78 billion – or $1 a share, a year earlier. Revenue also fell by 0.7 percent to $16.48 billion. The company now says it expects 2012 earnings per share of $5 to $5.07 per share, down from its April forecast of $5.05 to ... Read More