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On Thursday, August 26, DePuy Orthopaedics Inc., part of Johnson & Johnson, announced that it would be initiating a recall on two hip-replacement products, the ASR Hip Resurfacing System and the ASR XL Acetabular System, due to new data from the National Joint Registry (NJR) of England and Wales which shows higher-than-expected rates of a patients need for a second hip replacement, also known as a revision surgery, following use of their product.
In addition, the data from the National Joint Registry (NJR) also states that within five years, one in eight patients needed a revision surgery, which translates to a five-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System.
The two recalled products, both metal-on-metal hip replacements, are used to replace a worn or weakened part of the hip, which consists of a socket at the outer edge of the pelvis and a rounded bone atop the thigh bone that fits into that socket like a ball, according to the Associated Press. Total hip replacement involves replacing both parts at once.
According to the new data, the risk for a second replacement was highest among female patients, which comes as a surprise to health professionals, as DePuy said previous data "had shown lower revision rates and that the ASR hip was performing in line with other devices in its class."
This is the eleventh recall announced by Johnson & Johnson since September 2009 and has put the company under increased scrutiny from the FDA and Congress.