The New and Improved DePuy Revision Knee Replacement Device May Lead to More Bonding Failures and Tibia and Femur Fractures

DePuy Knee Lawsuit News

Strengthening the artificial knee joint transfers the stress from the joint to the knee joint glue, and then to the bones to which it is attached

Wednesday, February 13, 2019 - The problem that has led to the unacceptably high number of DePuy knee failures is not so much with the artificial joint itself as it is with the difficulty attaching the device to the tibia and femur bones. The mechanical joint itself is nearly perfectly designed with only small faults that the company corrected with a revised knee device, however, the strength of the joint only transfers the torque placed upon the knee to the bonding surface between bone and device, and if that holds, to the tibia and femur.

The Revision Knee Replacement device corrected the mechanical problems with the device but left the glue joint mostly unaddressed. As a matter of fact, the newer glue used to bond the new and improved Revision Knee may, in fact, be even less adequate than its predecessor that fails so often. An artificial knee glue has made its way to the market that has an antibiotic "built-in" to the compound to help fight off the infection that the glue so often causes. Yes, the DePuy Revision Knee may very well last the 15-20 years as the company advertises, but the bonding compound used only lasts a year or two and sometimes not at all.

DePuy Synthes has had a history of making faulty, malfunctioning knee replacement device glue. For example, in 2015, the company was forced to recall its SMARTSET GVH Gentamicin Bone Cement via an FDA Class II medical device recall. The FDA described the product as "A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis." Surgeons reported having difficulty in properly mixing the glue which tended to form clumps and not the smooth consistency that was preferred to properly fix the knee device to the bone. In another class II recall, the company had to retrieve all SmartSet GMV Endurance Gentamicin cement products, "self-curing, radiopaque, polymethyl methacrylate based cement, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk." All in all, over 20 separate recalls were conducted since 2013 of the knee cement or a sterile product used in the cementing of DePuy artificial joints.

To add to the device's bone attachment problems, the new and improved revision knee device has been redesigned to include a 2 to three-inch spike on either end that is presumably intended to be hammered into the bone marrow of the tibia below and femur above. Such a design again merely transfers the stress and torque from the knee to the bonding compound and then, if all goes well to the bone strength and density of the patient. This design may cause fractures in senior citizens, most of whom have bone density weakened by osteoporosis or otherwise simply diminished by old age. Even if the DePuy Revision knee is successful in reducing the number of debonding cases, it almost certainly will be met with an increase in fractures to the tibia and femur.

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