Biomet Hip Replacement Implant Recall

Biomet Hip Replacement Implant Recall

Biomet Hip Replacement Implant Recall System

In February 2001, the FDA announced that Biomet, US manufacturer of artificial hips, had made a voluntary recall of its hip replacement system following discovery of defects in the zirconia ceramic femoral heads. The ceramic femoral head components had been produced by the French manufacturer Saint Gobain Desmarquest, which distributes zirconia ceramic femoral heads to the orthopedic industry throughout the world.

Biomet recalled the defective product from the market after it found that the device was vulnerable to fracture at a higher than expected rate, causing failure of the hip implant system within 13 28 months. The recall applies to nine lots of the non implanted ceramic femoral head components, also known as Prozyr® Zirconia Heads, produced from January 1998 to September 1999, when Saint Gobain Desmarquest changed its manufacturing process, especially the heating procedure of the ceramic heads. However, the change is believed to have caused a negative impact on the ceramic femoral head components, which were found to become unstable soon after implantation.

Several other manufacturers of hip implants used this defective component in their hip replacement systems, including DePuy Orthopedics, Stryker Howmedica Osteonics, Encore Orthopedics, Smith & Nephew Inc., Osteoimplant Technology, Apex Surgical, and Zimmer Inc. The batch number of the recalled ceramic femoral head batches has the prefix "TH."  The recall only applies to ceramic femoral heads produced since the early 1998. It does not affect any femoral heads made of alumina ceramic.

Following the Biomet recall, all these companies followed suit and withdrewtheir artificial hip replacement systems from the market, saying that the product could fail and fracture, following which the patient would need to undergo a replacement and revision surgery. Even surgeons complain that they find it hard to remove and replace the defective components.

The FDA stated that there were problems with the ball portion of the artificial hip joint, which connects the pelvis and the femoral stem. Reports claim that the ball portion of the artificial hip joint is faulty, which has a propensity to become unstable and thus cause fracture. There are many cases where patients have reported to have heard a popping sound from their hip just before the device fractured, following which they started experiencing excruciating hip and groin pain.

The FDA received a number of reports that the components

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Zimmer Durom Hip Replacement Implant Lawsuit

Zimmer Durom Hip Replacement Implant Lawsuit

Zimmer Durom Hip Replacement Implant

In 2008, Zimmer Holdings suspended sale of Durom Acetabular Cup following numerous complaints of a high implant failure rate. Since 2006, when Durom Cup came to be used in the United States, numerous complaints and lawsuits have been filed against Zimemr Holdings. Most of the lawsuits filed against Zimmer allege that the defendant did not disclose the risks associated with the hip implant cup when it marketed the product. However, Zimmer continues to deny the allegations, precisely blaming the surgeons for the high hip implant failure rate. Many patients have complained that the Durom Cup failed within two years of implantation, as a result of which, they had to bear severe pain and undergo a revision surgery.

Patients complain of pain and stiffness following their hip replacement surgery with Durom Cup. They allege that they experience so much stiffness and sharp pain in the groin that they cannot walk properly. Most of the patients also allege that they even find it difficult to come down the stairs.

Zimmer Durom Cup Dangers

The Durom Cup had been implanted in more than 12,000 patients in the country from 2006 to 2008. According to reports, about 11 percent of the Durom Cup implants failed in the first two years. However, Zimmer claims that the product can last for 15 years, saying that the metal hip replacement system is far more durable than traditional implants.

In fact, the Durom Cup is a metal-on-metal hip replacement system, with multiple metal components designed to fit into a “ball and socket” formation. As the ball rotates and rubs against the cup-like socket, it sometimes presses against the edge of the cup, thus generating a large volume of microscopic metal shavings into the patient’s bloodstream. The metallic debris can be absorbed by the soft tissue, resulting in

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DePuy Hip Replacement Recall Lawsuit

DePuy Hip Replacement Recall Lawsuit

DePuy Pinnacle Hip Replacement Implant Ultamet Recall

Following the DePuy ASR recall, there have been numerous complaints that DePuy Pinnacle hip implant is causing similar problems when used with a metal liner. Patients and doctors demand that, with more than 1,300 adverse event reports filed with the FDA against Pinnacle hip implant, it is high time DePuy Orthopedics issued a recall for the device, which is reported to have a 13 percent failure rate. The device is linked to potential side effects, including severe pain, hip dislocation, hip replacement failure, metal toxicity, and need for a revision surgery in many cases.

The FDA approved the DePuy Pinnacle® Ultamet® metal acetabular inserts in 2001. However, not all Pinnacle hip devices are metal on metal, but the metal bearing surface poses the risk of revision compared to other bearing surfaces, including plastic, polyethylene, ceramic, and polymer. The Pinnacle metal on metal hip replacement system with a femoral head, particularly the one that is more than 32 mm, poses a threat of revision surgery. Though the Pinnacle Ultamet does not have as high a failure rate as ASR implants, a large number of incidences of

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Hip Replacement Implant Recall Lawsuit

Hip Replacement Implant Recall Lawsuit

DePuy Defective Hip Replacement Implant Recall

DePuy Orthopedics has issued a recall for two of its hip replacement systems following reports indicating a higher-than-normal implant failure rate. DePuy recall came after more than expected number of people had to undergo secondary surgery due to hip implant failure. Since their approval in 2003, DePuy ASR hip implants have been used in over 93,000 hip replacement surgeries. Hip implants generally last 15 years; however, many patients have complained that their artificial hips lasted only two or three years, following which they were required to undergo expensive and painful revision surgeries, which caused them more pain and loss of money.

The FDA has received over 300 complaints against DePuy Orthopedics regarding defective hips. Complaints against DePuy started surfacing in 2009; however, DePuy issued a recall only after a long wait of about 18 months, after its defective product had caused more harm to many other patients throughout the country.

Hip Replacement Implant Metal Toxicity

DePuy has recalled both products because of their high failure rate.DePuy’s metal-on-metal hip products use a metal ball and metal cup, which are installed in the place of the natural ball and socket hip. When DePuy launched its new metal-on-metal hips, it claimed that the product was stealthier than traditional hips made of metal and plastic. However, it ignored the risk of metal toxicity posed by metal-on-metal hip products. Even a number of complaints registered against DePuy claim that the metal-on-metal hip implants caused metal toxicity in many patients.

Analysts believe that when metal ions rub against each other as a result of friction and movement, these metal particles spread into the surrounding tissue and bloodstream. Further, these metal ions do not allow the cup to bond properly with the bone, causing cup loosening and hip fracture, besides other complications, including persistent pain, inflammation, discomfort, lethargy, dizziness, headache, gastrointestinal problems, food allergies, muscle and tissue damage, bone fractures, and Pseudotumors.

Metal toxicity causes heart problems, skin rashes, nerve damage, depression, numbness, loss of sensory and

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