ZIMMER

Description of Event or Problem

I HAD A COMPLETE LEFT KNEE REPLACEMENT ON (B)(6) 2008 AND (B)(6) 2011, I NEEDED A REVISED LEFT TIBIAL ARTHROPLASTY. THE TIBIAL COMPONENT FAILED AFTER 3 YEARS, THE ENTIRE TRAY SUNK DOWN INTO THE TIBIA AND THE COMPONENT WAS LOOSE AND MOVING AS I MOVED, ALSO THERE WAS EVIDENCE OF POLYETHYLENE DEBRIS WITHIN THE JOINT. I STARTED TO EXPERIENCE INCREASED PAIN, SWELLING, LIMITED RANGE OF MOTION, AND INSTABILITY ABOUT 27 MONTHS AFTER THE 2008 REPLACEMENT. ON (B)(6), MY ORTHOPEDIC SURGEON INFORMED ME THAT I NEEDED A TIBIAL REVISION SURGERY. I AM CONCERNED BECAUSE I HAD A ZIMMER NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE POSTERIOR STABILIZE LPS-FLEX, SIZE CD, LOT: 61021358, EDI: 00596403014, REF: (B)(4) AND A ZIMMER NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL COMPONENT PRECOAT, SIZE 4, LOT: 61029126, EDI: 00598003702, REF: (B)(4), ZIMMER NEXGEN COMPLETE KNEE SOLUTION TAPER STEM PLUG, LOT: 61069112, EDI: 00596009900, REF: 5960-99, ZIMMER NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL AUGMENT BLOCK PRECOAT, SIZE D, LOT: 60785650, EDI: 00599003410, REF: (B)(4). MY CONCERN IS THAT MY KNEE REPLACEMENT SHOULD HAVE LASTED 15-20 YEARS, I HAD PROBLEMS AFTER 27 MONTHS. THIS IS NOT THE TYPE OF SURGERY YOU WANT TO HAVE ONCE IN A LIFETIME, YET ALONE TWICE. I FEEL THE FDA SHOULD BE TAKING A BETTER LOOK AT THE ZIMMER NEXGEN KNEE COMPONENTS, THERE IS TOO HIGH OF A FAILURE RATE WITHIN THE FIRST THREE YEARS OF SURGERY.