The FDA has received many reports of the acetabular component of the Zimmer Durom cup loosening and moving, requiring revision surgeris on patients.
Contacting an Attorney
If you have been injured as a result of a Zimmer Durom cup for Hip Replacement product, you may be eligble for compensation and should contact a personal injury law firm who specializes in product liability litigation and medical device injury torts. Zimmer has had troubles with it’s hip parts in the past and were forced to recall another product in 2001 because the product was disintegrating.
Zimmer Company Background
Zimmer is a worldwide leader in joint replacement solutions for knee pain and hip pain, and provides comprehensive spine care solutions for acute and chronic back pain. The company also provides a broad range of trauma, dental implant, and orthopaedic surgical products. Founded in 1927, Zimmer is committed to providing effective techniques in hip replacement and knee replacement for orthopaedic surgeons who restore mobility and relieve the pain of osteoarthritis and traumatic injuries. Our minimally invasive hip and minimally invasive knee replacement systems and our wide range of related products and services make us valuable partners to health-care providers in more than 80 countries.
Zimmer Durom Cup Recall
The company voluntarily recalled the product in July of 2008, and the recall details include;
- Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 44/38, code D; REF 01.00214.144. The product is component of the Metasul LDH Head System intended for noninflammatory degenerative joint disease. (Hip replacement)
- The recall affected all units, was nationwide and totalled 19,014 cups.
- Recall numbers include # Z-2415-2008, # Z-2416-2008, # Z-2417-2008, # Z-2418-2008, # Z-2419-2008, # Z-2420-2008, # Z-2421-2008, # Z-2422-2008, # Z-2423-2008, # Z-2424-2008, # Z-2425-2008, # Z-2426-2008.
Orthopedic Surgeon Lawrence Dorr
On April 22, 2008, Dr. Lawrence Dorr, a renowned orthopedic surgeon decided it was time to inform his colleagues of his results the previous two years with the Zimmer Durom Cup, after he found that 14 of the 165 patients he treated had to undergo revision surgery within two years of the initial implantation. The letter Dr. Dorr wrote to his colleagues is included below.
April 22, 2008
To: All AAHKS Members
From: Larry Dorr, MD
This NOTICE is to inform you that we have had ten revisions in 165 hips and have four more that need to be revised using the Durom cup (Zimmer, Inc). This failure rate has occurred within the first two years. In the first year the x-rays looked perfect. We have revised four that did not have any radiolucent lines or migration (and John Moreland revised one). 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. It has tilted into varus. We do not believe the fixation surface is good on these cups. Also there is a circular cutting surface on the periphery of the cup that we believe prevents the cup from fully seating. We stopped using the cup after the first revisions. We have notified Zimmer. The FDA has been notified and we will notify them of our continued revisions.
The company does not believe it should pull the cup from the market so I am notifying all of my colleagues of our failure rate with this cup. I went through a similar scenario with the Sulzer cup failures where I was the only one experiencing revisions at the beginning and basically it was assumed that it was our technique. I can assure you that this goes beyond technique.
I learned my lesson in not informing everyone about this magnitude of failures with the Sulzer cup problem, so it is my obligation to do so with this cup. If you have any questions, do not hesitate to contact me.
Larry Dorr, MD
Hip Implant Lawyers
Hip Implant Attorneys – Robinson Calcagnie Robinson Shapiro Davis, Inc.