DePuy Compliance Manager: ASR Engineering Controls Inadequate


The latest disclosure in the ongoing DePuy ASR trial reveals that the controversial and faulty metal-on-metal hip device was not sufficiently assessed before being implanted in more than 93,000 patients worldwide. The trial is the first of some 10,000 filed and is being heard in Los Angeles Superior Court.

Yesterday, Jimmy Smith, a DePuy compliance manager discussed the report in videotaped testimony. According to Smith, said the Times, the report indicated that DePuy officials had not used appropriate engineering controls to determine potential device issues. “They did their job, but they could have done it better,” Smith said.

In separate testimony, Graham Isaac, a DePuy engineer, said that prior to selling the ASR, DePuy only tested the device’s performance on laboratory equipment and at only one angle of implantation, said the Times. The surgical technique used, the patient’s body structure, and the device’s flaws can all affect the angle at which the artificial hip is implanted. Also, noted the Times, given the ASR’s design flaw, the typical variance from the one angle tested created a situation in which the device’s joint cup and ball could strike one another, which enables release of medical debris into the patient’s body.

The ASR was globally recalled in August 2010; the so-called post-mortem review of the device was conducted three months later, in November. The analysis on this review was never released, noted the Times, and the device maker never conducted any further review when increasing complaints were being received in 2008-2009.

As the Times mentioned yesterday, Andrew Ekdahl, appointed to head the DePuy Orthopaedics division by Johnson & Johnson, was apparently aware of the device’s flaws three years before the 2010 recall. Prior to the recall, Ekdahl and other executives at the firm publicly stated that the hip device was performing very well; however, said the Times, newly released internal documents reveal a different situation.

Engineers at DePuy reviewed the ASR’s criteria and so-called “controls” or standards, which were used about 10 years prior when officials at the firm were attempting to determine how the ASR would perform. But, noted the Times, the version of the device sold in the United States was not clinically tested in patients and, because of this, officials only used controls for implant assessment. Also, although ASR records indicated “that the product is more likely to experience contact between the head and rim” when compared to competing implants, officials at DePuy did not consider the significant wear rate on the device that would be experienced with normal patient movement, the Times pointed out.

As we’ve long written, research has linked metal-on-metal hip implant devices, such as the DePuy ASR, to an increasing array of adverse events that include tissue necrosis, pain at the implant site that sometimes spreads to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and fluid collection/solid masses around the hip joint. The issue appears to be with the metal used in the construction of the implants, which was touted to last for at least two decades. More and more, reports and research indicate that some patients have required painful revision surgeries just two or three years after original implantation.

Earlier last month, the U.S. Food & Drug Administration (FDA) issued new guidelines for patients with metal-on-metal hip implants. The guidelines warned that the devices can cause bone and tissue damage due to the release of metal ions and also advised that patients who experience pain; swelling; a change in their ability to walk; or who hear noises emanating from the hip, such as popping, squeaking, and grinding, should speak with their physicians. These symptomatic patients should be considered for metal ion testing, the agency said. The FDA also recommended that metal-on-metal hip implant patients undergo regular physical examinations, routine radiographs, and diagnostic imaging for ongoing assessment of the patient reaction to metal-on-metal devices. From a legal standpoint, these changes are an important step in attempting to hold manufacturers responsible for dangers associated with their products.

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