Sales for the Zimmer Durom Cup were halted in July 2008, due to a high rate of failures in the United States requiring additional hip revision surgery. However, the Zimmer hip replacement part could soon be available again for doctors who have completed additional training about special surgical techniques needed to reduce the risk that the hip replacement will fail.
Since it was introduced in the United States in 2006, approximately 12,000 people have had a hip replacement with the Zimmer Durom Acetabular Component (Cup).
Safety concerns began to emerge earlier this year after prominent orthopedic surgeon Dr. Larry Dorr, highlighted a growing problem with these hip replacements parts failing at a surprising rate.
On July 22, 2008, Zimmer decided to stop selling the Durom Cup after their own investigation found that some doctors were experiencing hip failure rates of 5.7%. At that time, they indicated that the Zimmer Durom Cup would be reintroduced after revisions were made to the label and a new surgical training program was developed to highlight special techniques that must be used with the Durom Cup that are not necessary for most other hip replacement parts.
Since the recall, a number of lawyers have begun reviewing and filing Zimmer Durom lawsuits on behalf of individuals who have had their hip replacement fail after receiving the components. The lawsuits allege that Zimmer failed to provide adequate warnings and instructions to surgeons about the special surgical techniques that are required for the hip replacement part.
On August 16, 2008, Zimmer sent a letter to surgeons in the United States announcing new product labeling and indicating that they would be making the Duron Cup available again to doctors who complete an on-line training program.
The internet training, which was made available starting August 19, 2008, covers aspects of the Durom Cup design, pre-operative planning and detailed instructions on the surgical techniques needed to implant the device. The program includes videos, information from experts and questions to evaluate comprehension.
Zimmer has also developed web casts which provides an opportunity for surgeons to ask live questions of experts, hands-on training courses involving the Durom Cup and surgeon-to-surgeon training.
The first Zimmer Institute Surgical Skill Course involving the use of the Durom Cup in a controlled environment with cadavers was held last week, on September 25, 2008 in Baltimore, Maryland. Additional sessions are scheduled throughout October in Indiana, Colorado and Arizona, with more dates to be announced at a later time.
It is unclear whether doctors will be quick to re-adopt the Zimmer Durom Cup after the safety of the hip implant has been called into question. Loosening of the hip replacement parts associated with Zimmer Durom Cup failures could result in the need for additional hip surgery to revise the implant, exposing the patient to additional risk.