In 2008, Dorr told of his experiences with Durom Cup while addressing his fellow surgeons. In his official letter, he discussed 10 surgeries of the 165 surgeries he had performed where he had to do corrective surgery. The following are the points he made:
- Revisions were necessary due to the loose implants
- Inadequate fixation surface
- A circular surface on the implant made it difficult for it to be seated properly.
Later on, Dorr found out that fellow doctors were experiencing the same problems; however, Zimmer said the problem was with Dorr’s methods and not the Durom Cup.
Durom Cup’s Temporary Suspension
After investigating issues with Durom Cup, Zimmer instructed U.S. surgeons not to use the model for implants. The FDA stated that this suspension was because the surgical method or instructions for using the product were insufficient.
Zimmer also suspended the sale of the product temporarily and hinted that it might re-label the model and provide further training on how to position and install the device. This suspension went for two months (July-August) at which time non-US regions had no sales for the Durom Cup product.
Zimmer made a statement saying that there was no evidence of defects in the manufacture of the implant.
Lawsuits against Zimmer Hip Replacement
Zimmer has been sued a couple of times by patients who have had the device implanted in them. These victims are seeking compensation for the pain and reimbursement for costs they have incurred in hospital. In 2008, the company established a fund of $69 million to pay for the claims that satisfied particular requirements. This fund was based on Zimmer’s estimation of their liability with regard to the revision surgeries brought about by the product.
Zimmer’s Durom Acetabular Component
Durom Actebular Device, normally called Durom Cup is a replacement of an individual’s natural acetabulum. The acetabulum cavity is below the hipbone and has the shape of a cup.