KNEE IMPLANT MANUFACTURERS
aRTIFICIAL KNEE JOINT MANUFACTURERS FACE INCREASED SCRUTINY, AND THOUSANDS OF LAWSUITS, OVER RECALLED PRODUCTS AND HIGH FAIRLURE RATES. IN 2007, FOUR OF THE NATIONS LARGEST KNEE IMPLANT MANUFACTURES AGREED TO PAY $310 million in penalties to settle federal charges stating that they PAID SURGEONS TO USE THEIR DEVICES.THE COMPANIES WERE ZIMMER, DEPUY, SMITH NEPHEW,STRYKER AND BIOMET.
ZIMMER MANUFACTURES THREE KNEE COMPONENTS THAT HAVE HIGHER THAN NORMAL FAILURE RATES. ZIMMER RECALLED COMPONENT IN 2010 AFTER REPORTS INDICATED THE LOCKING SCREWS AND STEM EXTENSIONS FAILED TO INTERLOCK CORRECTLY. ZIMMER PAID 1 BILLION TO SETTLE THOUSANDS OF LAWSUITS . THE SETTLEMENT CAME A YEAR AFTER THE DEFECTIVE IMPLANTS WERE RECALLED OVER AN OILY SUBSTANCE THAT HAD BEEN LEFT ON SOME OF THEM DURING THE MANUFACTURING PROCESS.
DEPUY IS ONE OF THE LARGEST JOINT REPLACEMENT MANUFACTURES IN THE WORLD. HOWEVER, THEY HAVE RECALLED SEVERAL KNEE COMPONENTS OVER THE YEARS. THE COMPONENT HAD A HIGHER THAN NORMAL REVISION RATE.
SMITH & NEWTON RECALLED IT OXIMIUM KNEE DEVICES AFTER REPORTS OF PAIN, LOOSENING AND REVISION SURGERIES. IN 2008 THEY RECALLED KNEE MODELS BECAUSE THE IMPLANTS HAD A HIGHER THEN SPECIFIED LEVELS OF IRON. A THIRD RECALL WAS ISSUED IN 2010 FOR THE JOURNEY TIBIAL BASEPLATE KNEE COMPONENT BECAUSE THE BASE PLATES AND INSERTS WERE PRONE TO BREAKING.
STRYKER IN 2012 RECALLED 26,000 OF ITS UNICOMPARTMENTAL KNEE SYSTEMS OVER HIGHER REVISION RATES. THE RECALL CAME SEVERAL YEARS AFTER THE FDA WARNED STRYKER ABOUT PROCEDURAL PROBLEMS AT 2 OF IT JOINT MANUFACTURING FACILITES. IN 2007 WARNING LETTERS TARGETED TWO KNEE COMPONENTS, AND OTHER JOINT COMPONENTS.
STRYKER AND SMITH & NEPHEW HAVE MERGED IN 2015
BIOMET RECALLED ITS FEMORAL COMPONENT BECAUSE IT WAS MISLABELED. IN 2008 THE COMPANY ISSUED ANOTHER RECALL BECAUSE THE SIZING INFORMATION WAS INCORRECT. IN ADDITION, THEY RECALLED SURGIACAL INSTRUMENTS USED TO PERFORM KNEE REPLACEMENTS. THE INSTRUMENTS WERE ASSEMBLED IMPROPERLY.
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Knee Replacement