Zimmer Durom

The Zimmer Durom Cup was first sold in the U.S. in 2006. Approximately 12,000 patients were implanted with the device.  After a well-known Los Angeles orthopedic surgeon reported Zimmer Durom Cup problems to the American Association of Hip and Knee Surgeons, Zimmer Cup began to receive increased attention. 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.

Zimmer Holdings announced on July 24, 2008, that 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.

Sulzer Inter-Op

Sulzer Orthopedics, Inc. recalled 30,000 units of its Inter-Op Acetabular Shell Hip Implant in December 2000. A manufacturing error,  contaminated the implants with a lubricant that prevented a recipient’s bone from adhering to the implant. This led to 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.  Patients who received a faulty implant that did not need surgery were paid about $1,000 each.

Stryker Trident

In January 2008, another orthopedic manufacturer, Stryker Corporation, issued a product recall. Two units were affected: the Trident Acetabular PSL Cup and the Trident Hemispherical Cup. Between 2005 and 2007, the had FDA received many complaints about these products from patients, some of whom required revision surgery. These complaints included reports of migration of hip parts, broken hip replacement parts, pain, queaking, and others issues. These 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. In November 2007, the FDA addressed its concerns in a warning letter to Stryker. 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.