An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.
The company’s analysis also suggests that the implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have already had painful and costly procedures to replace it.
The episode represents one of the biggest medical device failures in recent decades.
About 93,000 patients worldwide received an A.S.R., about one-third of them in the United States.
Hip implants, which are generally made from metal and plastic, often last for 15 years before they wear out and need to be replaced. Such devices can fail prematurely for a variety of reasons, but the early replacement rate is typically 1 percent after a year, or 5 percent at five years.
Based on the number of patients who had already undergone device replacement at the time, DePuy estimated that about 37 percent of patients who got an A.S.R. might need to have it replaced within five years of receiving it.