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Biomet denied summary judgment in latest metal hip implant trial

A favorable ruling by U.S. District Judge Robert L. Miller Jr., in litigation involving allegedly defectively designed metal-on-metal hip implants manufactured by Biomet will help move hundreds of plaintiffs in the multidistrict litigation toward either their day in court or a resolution of their claims, said Navan Ward Jr., Beasley Allen attorney and co-lead counsel for the Biomet Plaintiffs Steering Committee. The favorable rulings by Judge Miller involve two bids by Biomet to dismiss certain claims in the multidistrict litigation that alleges the company’s metal-on-metal hip implants cause injuries to patients such as metallosis, a type of metal poisoning. The ... Read More

Small-Head Metal-on-Metal Hip Implants Fail Frequently

Large-diameter metal-on-metal hips were thought to be an independent risk factor in hip failure, besides the material from which the prosthetic was made. But according to a recent study, adverse reactions to metal debris from small-headed metal-on-metal Articular Surface Replacement (ASR) hips are even more common than originally thought. In the study, 482 hips (424 patients) were reviewed. After the ASR small-diameter hip was recalled at an average of 4.9 years post-op, 379 patients (435 hips) agreed to a screening that measured cobalt and chromium in the blood. Metal-on-metal hip implants are created with a ball-and-cup design made up of a cobalt-chromium ... Read More

Metal-on-metal Hip Recipients Experience Adverse Soft-Tissue Reaction to Metal Debris, Study shows

In a study at Coxa Hospital for Joint Replacement in Finland, researchers assessed 176 patients who received metal-on-metal hip implants (203 hips) and found that 84 of those hips required revision surgery. In 87 percent of these revisions, adverse soft-tissue reaction to metal debris (ARMD) was diagnosed. Additionally, a larger femoral diameter and stem type had a higher risk of ARMD, metallosis, and device failure. Metal-on-metal hip designs, made by a number of medical device manufacturers such as Wright Medical, DePuy Orthopaedics and its parent company Johnson & Johnson, Stryker, Smith & Nephew and Zimmer Biomet Holdings, are made up of a cobalt-chromium alloy, which has been ... Read More

Plaintiffs Push to Consolidate Smith & Nephew Metal-on-Metal Hip claims in MDL

On Feb. 1, plaintiffs filed a petition asking the Judicial Panel on Multidistrict Litigation (JPML) to consider consolidating complaints against Smith & Nephew over its Birmingham Hip Resurfacing (BHR) and R3 Acetabular System devices. As many as 31 cases are still pending in 22 federal district courts, according to the petition, and dozens more are expected to flood in. Pretrial coordination before a single judge in Maryland would facilitate resolution of the claims, the plaintiffs say. In June of 2012, Smith & Nephew recalled its R3 Acetabular System, an optional metal liner component used in hip implant devices. This includes about 7,700 metal liners that ... Read More

Cobalt and Chromium Toxicity from Metal-on-Metal Hip Resulted in Neuropsychiatric Symptoms

According to a study published in January in BMC Psychiatry, an online journal of psychiatric disorders, cobalt and chromium toxicity from metal-on-metal hip implant failure resulted in neuropsychiatric complications after revision surgery. Metal-on-metal hip implants are designed using a metal ball and metal socket made of a cobalt-chromium alloy. When the parts rub together during normal use, the parts may shed metal ions, which can pollute the bloodstream and damage the surrounding tissue. The normal range occurring in a person’s system due to normal environmental exposure is 0–20 nmol/l for cobalt and 0–100 nmol/l for chromium. Nine of the 10 patients in this ... Read More

Metal-on-metal hip implant settlement cuts Into Stryker Earnings

Profits for Stryker, a medical device manufacturing giant, have taken a 2.3 percent cut year-over-year when projections had predicted they’d be up by 14.1 percent. This is likely due to the number of lawsuits regarding the company’s Rejuvenate or ABG II modular metal-on-metal neck hip stems. Information about the earnings came about a month after Stryker announced that Howmedica Osteonics, its subsidiary, had reached a settlement with patients who required revision surgery to correct problems with their new Rejuvenate or ABG II metal-on-metal hips. The metal-on-metal hip implant designs, made by a number of medical device manufacturers such as Wright Medical, DePuy Orthopaedics and its parent company Johnson & Johnson; Smith & Nephew, and Zimmer Biomet ... Read More

Stryker Reaches Settlement Over Metal-on-Metal Hip device Failure

Stryker, a medical device manufacturing company and its subsidiary, Howmedica Osteonics, have reached a settlement for patients who were required to have revision surgery to correct problems with their Rejuvenate or ABG II modular metal-on-metal neck hip stems. The defective hip design, which was recalled in July of 2012, earned the company about 4,000 lawsuits that were settled in an agreement reached by Court-appointed committees and attorneys. The settlement included any and all patients who received revision surgery prior to Dec. 19, 2016. The defective design had potential for corrosion that led to tissue damage and blood poisoning if the metal ions were absorbed into the bloodstream. The symptoms included ... Read More

Indiana man claims DePuy Orthopaedics metal-on-metal hip implant is the source of ‘constant debilitating pain’

Just four days after a Texas jury awarded six plaintiffs a $1 billion verdict against DePuy Orthopaedics and its parent company, Johnson & Johnson related to the company’s metal-on-metal hip implant, a new lawsuit is filed about a similar case. An Indiana man filed a lawsuit against DePuy, the maker of his metal-on-metal hip implant, saying it caused him “constant debilitating pain and instability” because of the “friction wear from the movement at the joint.” He received the hip implant in 2008, but was forced to have revision surgery just six years later to fix the agonizing problems. The metal-on-metal implants have been ... Read More

FDA Panel Says Metal-on-Metal Hip Implants are not recommended for Most Patients

The U.S. Food and Drug Administration (FDA) panel of medical device experts convened recently, advising against metal-on-metal hip implants, just short of banning the device altogether. The panel also advised that any patients who have received the devices should be evaluated with an X-ray and blood tests, particularly if they are experiencing pain or other symptoms that might indicate device failure. In particular, blood tests would allow detection of metal in the bloodstream, which could result in metallosis, a dangerous condition of metal poisoning in the blood. The metal-on-metal hip designs, made by a number of medical device manufacturers such as Wright Medical, ... Read More

European Medical Device Regulations Tightened Due to Metal-on-Metal Hip Implant Safety Concerns

New medical device regulations (MDR) have been put in place by European Parliament after four years of negotiation. The decision to tighten regulation was spurred by safety concerns over breast implants and metal-on-metal hips. The regulation amendments are expected to begin in early 2017, and medtechs will be allowed three years to comply. If the medical products fail to meet the new regulation standards, the manufacturer will lose their CE rating, which allows legal marketing of the product. The new regulations include stricter rules regarding clinical trials, quality management, and marketing necessities such as product labeling and design. Regulators will now inspect Class ... Read More