Amid lawsuits concerning its Pinnacle metal-on-metal hip implant, Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics won U.S. Food & Drug Administration clearance for its next-generation Pinnacle ceramic-on-metal hip implant.
Ceramic-on-metal is a novel combination in the hip implant market, having undergone two-year controlled, randomized, multicenter, non-inferiority clinical study and laboratory testing as part of the clearance process.
The study found no clinical difference between 194 patients who received JNJ’s new ceramic-on-metal system and 196 patients in a control group who received metal-on-metal implants, according to the FDA release.
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Depuy is already under a differently hued spotlight for ongoing lawsuits against its previous generation of metal-on-metal Pinnacle hip implant systems over findings that they shed minute metal particles into a patient’s bloodstream as the hip’s ball joint wears on the metal cup.
The lawsuit, a consolidation of 57 different suits against the implants, also include Depuy’s ASR hip implant and allege that the New Brunswick, N.J.-based medical conglomerate knew of problems with the implant but left it on the market anyway.
Depuy voluntarily recalled the ASR implant in August 2010 after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.
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MassDevice Staff Website The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
