Knee Replacement

There have been problems associated with the manufacturing processes of knee replacement products.

Replacement surgeries are now a common procedure as they can give great relief to patients with arthritis or joint injuries. Replacement of joints reduces pain, as well as increasing mobility, and should last for 15-20 years. However there have been instances where faulty products have caused pain, distress and increased the need for additional surgeries.

Gamma irradiation has been used to sterilize the replacement parts. These parts are made with ultra high molecular weight polyethylene. However, it has been found that the sterilizing process has caused oxidation putting the devices at risk of breaking up after they have been implanted in the patient. This failure of the implants can cause the body to react against the parts and also to react against the actual bone causing a condition known as osteolysis. Patients then need the devices replaced.

Another condition known as metalosis is caused my metal fragments detaching from faulty implant.

Medical device manufacturers have stopped using gamma irradiation and moved to ethylene oxide or gas plasma as the sterilization process. This helps prevents oxidation.

Products manufactured by Johnson & Johnson, Biomet, Apex Surgical LLC, Encore Orthopedics Inc., Osteoimplant Technology Inc., Smith & Nephew Inc., Stryker Howmedica Osteonics, Zimmer Inc, Sulzer Orthopedics and Depuy have been associated with lawsuits.

 

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