|
The Durom® Cup was manufactured by Zimmer Holdings, the nation’s largest manufacturer of orthopedic medical devices.
Officially titled the Durom® Acetabulum Component, the device was approved for use in the U.S. in 2006. Zimmer Holdings suspended sales of the Durom® Cup in July of 2008, after reports that the implants were failing and requiring additional surgeries. It is estimated that more than 12,000 Durom® Hip Cups had been implanted into patients. The Durom® Acetabular Cup is intended for patients with noninflammatory degenerative joint disease like avascular necrosis, which is bone death caused by poor blood supply, arthritis, and inflammatory joint disease like rheumatoid arthritis. It is also prescribed for conditions needing a longer-lasting fix, such as replacements for previously failed replacement surgeries.
Imbedded in the hip socket in hip replacement surgery, The Durom® Cup is meant to be used with the Metasul® LDH™ large diameter head, which forms the ‘ball’ of the ball and socket that replaces the hip joint.
“Zimmer has received some reports of persistent post-operative pain, dislocation, and loosening of the acetabular implant leading to revision surgery.” Letter from Zimmer to Sandra Williams, FDA Compliance Officer on July 31, 2008 Signs the Durom® Cup Implant may be Failing These symptoms have appeared after Durom® Cup implantation, and could potentially show up much later: • Little or no pain relief after the surgery
• Feeling like your leg wants to give out on you
• Something seems loose in the hip
• Pain when rising from a chair
• Pain in the groin when moving upright
• Less pain when at rest
• Difficulty climbing stairs – limping, little endurance
A frustrating effect was noted by the doctors reporting the Durom® Cup failure: the x-rays can look as if nothing is wrong.
Some Reported outcomes of Durom® Cup Implantation Include (but are not limited to) the following
In the FDA report, doctors reported the following potential outcomes of implantation with the Durom® Cup:
• The cup loosening in the body
• Lack of ingrowth
• Revision surgery needed
• Infection
• Cup being too small
• Pain
• Osteolysis (loose particles make the bone grow away from the implant)
• Lesions If you or a loved one has been surgically implanted with a Durom® cup, please contact us immediately for a free consultation. The device may not fail for some time after surgery. Contact Us If you had hip replacement surgery between 2006 and 2008, you may want to check your doctor’s medical records and verify whether or not implantation with the Durom® Cup has taken place.
For a free evaluation of your potential claim, call 1-888-446-8087, or fill out an intake form on this website by clicking on "Can We Help You?" on the upper right hand corner of the home page.
The initial consultation is free of charge, and if we agree to accept your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. Do not delay - your rights and your compensation could be lost.
We are always interested in hearing from implant patients of any kind experiencing problems. Even if your implant is not the type discussed on this page, please contact us to explain your situation.
|
