Durom Cup Hip Replacement Parts
Thursday, August 21st, 2008The Durom Cup is manufactured by Zimmer Inc. This medical device was created in 2006 and has been used in more than 12,000 U.S. patients as a part of hip replacement surgeries.
On July 22, 2008, Zimmer Inc. ceased the sales of their Durom Cup hip replacement parts in the United States after doctors reported having to do revisions and further hip surgery after the using the Zimmer products.
However, some experts feel that suspension of sales came far too late for many patients. Dr. Lawrence D. Dorr, an orthopedic surgeon and medical director of the Dorr Institute for Arthritis Research and Education said in April 2008 that the failure rate of the Durom Cup is with the first two years of implant. He noted that after the first year, the x-rays looked perfect, but followed that up with “These early cups fooled us, but the symptoms were so classic for a loose implant that we operated the patients. When we hit on the edge of the cup it would just pop free. As time goes by the cups begin developing radiolucent lines. We now have one cup at two years that has actually migrated a short distance.” He didn’t feel that the fixation surface is good on the Durom cup and that circular cutting surface on the edge of the cup prevented the cup from fully seating. He said he and his staff of doctors stopped using the cup after the first revisions.
Zimmer finally agreed to start an investigation into the allegations of problems with the cup in May 2008 after numerous complaints by surgeons. The company reviewed over 3,100 patient cases before deciding that the technology and design of the Durom cup required additional instructions and training. They plan to develop instructions which will help the surgeon reduce the risk of problems when the implant is performed. Zimmer also stated that it planned to put into practice a surgical training program in the U.S. and only allow surgeons who had completed the training to perform hip replacements using the Durom cup.
Rather than issue a recall, Zimmer merely suspended sales of the product in the United States until the new procedures could be put in place, feeling that it was lack of proper training and not a manufacturing defect that caused all the additional surgeries.
But, is Zimmer at fault for not providing adequate instructions and trainings from the beginning? It appears that perhaps even the shareholders of Zimmer stock believe the product is faulty and was left on the market too long. Shareholders who purchased stock between January 28, 2008 and July 21, 2008 recently filed a class action lawsuit against Zimmer. The lawsuit, filed in the Southern District of Indiana, says that Zimmer failed to disclose that a disproportionate number of patients receiving the implant then having to undergo corrective surgeries. The day after the suspension of sales was announced, the Zimmer stock declined from $70.88 per share to $66.01.
If you or someone you know has had the Zimmer Durom cup hip replacement and experienced unexplained hip pain three months or more after the original surgery or loosening of the parts which required additional surgeries, you may want to seek legal advice. Many lawyers will offer a free consultation to find out if you have a case against Zimmer or not due to faulty parts.