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Formally known as the Durom Acetabular Component, the Zimmer Durom Cup entered the market in 2006 as a newer, supposedly advanced type of hip replacement. Unlike previous implants, it utilized a single piece of metal, which then fused the hip socket in place without cement or screws. Zimmer further advertised it to younger patients, claiming it would outlive traditional systems.
But, rather than have the hip bone grow into its cup-like form, this product designed for total replacement, or arthroplasty, has had a high early failure rate and resulting number of revision procedures. In response, many of the 12,000 recipients have come forward to file lawsuits against the manufacturer.
Just a few years after the Durom Cup’s introduction, patients began complaining of pain. In fact, to date, roughly 5.7 percent out of the total group given this implant have needed a revision procedure to correct:
- Premature loosening
- Swelling that never went away
- Damaged tissue and bone
- High amounts of metal in the body leading to poisoning
- Heterotopic ossification
- Osteonecrosis or avascular necrosis, a condition in which blood cannot reach the bone, which then leads to bone cell death.
Yet, in spite of these reports, Zimmer told doctors to hold onto the implants.
By 2008, however, Zimmer decided to suspend the Durom Cup’s sales after reviewing data from 3,000 cases. At the time, the manufacturer determined surgeons weren’t correctly inserting the device, so it updated its instructions with more detailed directions for medical professionals to follow during total hip replacements.
One factor leading to the suspension was a letter from Dr. Larry Dorr to the American Association of Hip and Knee Surgeons. In it, Dorr detailed specific problems he experienced with the Durom Cup: Out of the 165 he implanted, 14 required revision procedures just two years after the surgery. Behind this, Dorr stated, were issues with the Cup’s fixation surface and a circular cutting surface on its periphery that never fully sealed. Additionally, Dorr’s letter mentioned that X-rays never showed the implant loosening, but patients continued to display such symptoms. In response, as Dorr claimed the Durom Cup required far more surgical precision than it initially let on, he said doctors should be given more training and better instructions.
While Zimmer followed through, it put the Durom Cup back on the market two months later. Two years after the letter, however, the company said the device’s failure wasn’t a result of their design but rather Dorr’s technique, which they claimed prevented the implant from working as it should have.
At the same time, while Zimmer didn’t issue its own recall, the FDA did. In 2008, the government put out a class II recall for all 19,000 Durom Cups, claiming the device was misbranded and that its label was “false and misleading.”
By 2010, Senator Charles E. Grassley questioned how Zimmer tracked its complaints and its devices’ long-term performance. Grassley went after the company when a New York Times piece had Zimmer’s consultants claiming the company’s products, such as the Natural Knee System and Persona Knee System, may have defects. But, here, too, Zimmer put the blame on the doctors for incorrect surgical technique.
Since these instances, studies have looked at the Durom Cup. Data has shown that its revision rate may, in fact, be as high as 15 percent, and another 2010 study, by Berton et al, indicates it has a low survival rate – just five years – compared to similar systems on the market.
Plaintiffs, in response to both the recall and allegations made, have started filing lawsuits against Zimmer. Court documents show they claim Zimmer not only didn’t provide sufficient instructions and training to surgeons, but after multiple complaints, the company additionally didn’t warn physicians about the potential defects, nor did it issue a proper recall. Further, plaintiffs state the manufacturer was not clear about its failure rate and risks, thus providing them and medical professionals with incomplete information.
So far, about 300 lawsuits have been filed against Zimmer and have been consolidated into multi-district litigation (MDL).