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At the beginning of 2011, DePuy Orthopaedics said they were phasing out the ASR Hip Implant because of declining sales, but never mentioned the high failure rate data from an Australian implant registry. In March 2011, The New York Times reported that DePuy issued its first warning to doctors and patients about the high early failure rate. [1]
The analysis of 402,051 hip replacements showed that 6.2% of metal-on-metal hip implants had failed within five years, compared to 1.7% of metal-on-plastic and 2.3% of ceramic-on-ceramic hip implants. Each 1 mm (0.039 in) increase in head size of metal-on-metal hip implants was associated with a 2% increase in failure rate. [63]
On February 10, 2011, the U.S. FDA issued a patient advisory on metal-metal hip implants, stating it was continuing to gather and review all available information about metal-on-metal hip systems. [4] On June 27–28, 2012, an advisory panel met to decide whether to impose new standards.
Between its massive over-the-counter children's medicines recall back in 2010 to its recent headache-inducing hip implant recalls, J&J. Skip to main content. Sign in. Mail. 24/7 Help. For premium ...
Johnson & Johnson and its DePuy Orthopaedics unit have agreed to pay $120 million to resolve deceptive marketing claims by several U.S. states.
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Though rare, metallosis has been observed at an estimated incidence of 5% of metal joint implant patients over the last 40 years. Women may be at slightly higher risk than men. If metallosis occurs, it may involve the hip and knee joints, the shoulder, [2] wrist, [3] elbow joints, [4] or spine. [5]
All hip prostheses fail in some patients, but it is expected that the rate will be about 1% a year. [145] Pathologically, the failing prosthesis had several effects. Metal debris from wear of the implant led to a reaction that destroyed the soft tissues surrounding the joint, leaving some patients with long term disability.