Archive for the ‘Defective Medical Devices’ Category

DePuy halts ASR hip implant much too late

Wednesday, March 10th, 2010

After more than two years of problem reports, DePuy Orthopaedics finally decided to withdraw its ASR hip implants from the market, because the ASR hip implant was failing in traditional hip replacements only a few years after implant, requiring costly and painful replacement operations.

DePuy ASR hip implant defective - chart showing increasing complaints to FDAIn a March 6 letter to doctors, DePuy admitted that the “metal-on-metal” ASR hip implant has a high failure rate and should not be used in traditional hip replacements.  A DePuy statement to the press admitted that “this is new and important information surgeons who continue to use ASR should have to inform their clinical decision making.”

The ASR model is often used in “hip resurfacing,” which is an alternative to traditional hip replacement. However, this method is not approved for use in the United States. The FDA has only approved the ASR for use in traditional hip replacement.

The FDA has received about 300 complaints about the ASR since 2008. Most of the patients lodging complaints had undergone an operation to replace the implant.  It was only after Johnson & Johnson saw slowing sales of the hip implant that they made the announcement that the device is unsafe.

Some surgeons have long said they believe the ASR design is defective and is prone to problems.  Orthopedic experts had recently been very critical of the hip implant, saying DePuy should have stopped selling the device much sooner.

DePuy withdrew the ASR from the Australian market in December, but kept it on the American market until the March 6 announcement.

The law firm of Aylstock, Witkin, Kreis & Overholtz (AWKO Law) has been actively engaged in defective medical device litigation for years.  For more information about patients’ legal rights, DePuy ASR patients and their families can contact the lawyers of AWKO Law at www.awkolaw.com (888-255-2956).

Defect in Calaxo screws causes problems after ACL surgery

Friday, July 24th, 2009

In August of 2007, only a year after initial approval, the FDA recalled the Calaxo Osteoconductive Interference Screw sold by orthopedic company Smith & Nephew.

The recall came after a sudden increase in injuries to patients who had the bioabsorbable screws implanted in their knees during anterior cruciate ligament (ACL) surgery. The screws were found to break and fracture leaving fragments in the surrounding tissue. Patients reported suffering from painful swelling, infection, and fluid build-up in repaired knees. The post injury diagnosis is commonly referred to as “pre-tibial soft tissue swelling”.

As a result of the splintering of the device, some patients had to undergo local debridement which requires the surgical removal of affected tissue and/or bone. Aspiratation of the knee and analysis of the fluid for infection and particulate matter is important as a first step towards diagnosing the issue. However, a scope of the area in which the screws were affixed may be necessary.

If you, or someone you know, has endured difficulties with the Calaxo screw, possibly after ACL surgery, please contact us to discuss your legal rights.