DePuy Orthopaedics announced the recall of two hip replacement devices in August 2010. The units, the ASR XL Acetabular System and the ASR Hip Resurfacing System, were recalled due to a five-year revision rate that was twice the industry average. Approximately 93,000 patients have received an ASR implant since 2003, the year the ASR was first introduced. DePuy’s recall might be the latest by a major orthopedic manufacturer, but it is by no means the first. Over the last decade, other major manufacturers of artificial hips have taken similar action.
In December 2000, Sulzer Orthopedics, Inc. recalled 30,000 units of its Inter-Op Acetabular Shell Hip Implant. Due to a manufacturing error, the implants were contaminated with a lubricant that prevented a recipient’s bone from adhering to the implant. This led to excruciating pain and other complications for many recipients. Approximately 3,500 people required a second replacement hip.
In what would emerge as a landmark hip replacement class action settlement, $1 billion was paid by Sulzer to victims. Those who underwent revision surgery received around $206,000 each, while those patients who received a faulty implant but did not require surgery were paid about $1,000 each.
On July 24, 2008, Zimmer Holdings announced it would suspend U.S. sales of its Zimmer Durom Cup. (Note that the product was never officially recalled, and the company intends to reintroduce the device at a later date). The decision was made after some doctors complained that the device was failing in their patients, making a second hip replacement surgery necessary.
Since the Zimmer Durom Cup was first sold in the U.S. in 2006, approximately 12,000 patients were implanted with the device. Problems with the Zimmer Cup received increased attention after a well-known Los Angeles orthopedic surgeon reported Zimmer Durom Cup problems to the American Association of Hip and Knee Surgeons. This prompted Zimmer to investigate the problems in May 2008. After declaring that its efforts uncovered no “evidence of defect,” the device maker did admit that even experienced surgeons found the Durom Cup difficult to implant. Zimmer therefore issued the July 2008 suspension of sales as it made plans to revise implantation instructions and train surgeons.
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Another orthopedic manufacturer, Stryker Corporation, issued a product recall in January 2008. It affected two units: the Trident Acetabular PSL Cup and the Trident Hemispherical Cup. The had FDA received many complaints about these products from patients between 2005 and 2007, some of whom required revision surgery. These complaints, which included reports of pain, broken hip replacement parts, migration of hip parts, squeaking, and others issues, prompted the FDA to inspect Stryker’s manufacturing facility in New Jersey, where the agency uncovered numerous safety violations, including the presence of disease-causing bacteria. The FDA addressed its concerns in a warning letter to Stryker in November 2007. To make matters worse, the FDA had already issued a similar warning to Stryker in March 2007 regarding problems with testing procedures at the company’s Ireland plant. The Stryker hip replacement recall finally came after an internal investigation by Stryker found that the recalled products might contain excessive “manufacturing residuals.”
While there are considerable similarities between the DePuy recall and the situations described above, there are also key differences. In regards to Zimmer, its Durom Cup, like the ASR devices, appeared to suffer from a design defect. Zimmer, however, unlike DePuy, never issued a recall. Both Sulzer and Stryker recalled its hip replacement devices due to a manufacturing defect, while it appears that DePuy’s ASR units contain a design defect. And while it might be tempting to assume that the DePuy hip replacement lawsuits will play out (and pay out) the same way the Sulzer lawsuits did, there is no guarantee that injured ASR recipients will receive similar compensation.