Hylamer was introduced by DePuy Orthopaedics (now a subsidiary of Johnson and Johnson) in 1987 as a modified polyethylene developed to reduce wear in total joint replacement components, including hip, knee, shoulder, and elbow joint replacements. Initially all Hylamer components were sterilized by gamma-irradiation in air. Subsequently the Hylamer components were sterilized by different processing methods. In the late 1990s, Hylamer was withdrawn from the market.

In September of 2001, the British Government's Medical Devices Agency issued a voluntary recall of knee implant Hylamer liners sterilized with gamma radiation in air. The British government issued its warning following a review of hip patients at one hospital which showed an extremely high failure rate of 67.6% five years after the prosthesis was implanted. This was more than 13 times the expected rate of failure. Patients were instructed to return to their orthopedic surgeon for clinical assessment of evidence of accelerated wear, progressive bone degeneration or fracture of the liner.

At present no similar warning or recall to the one issued by the British Government has been issued by the Food and Drug Administration here in the United States. However, that is not surprising as the FDA has to date entirely ignored the problems caused by gamma irradiation of polyethylene and extended shelf life of gamma irritated polyethylene. However, it appears as if the problems seen in Britain with Hylamer are indeed also here in the United States.

If you believe that your joint replacement device utilizing Hylamer failed because it was defective, the trial lawyers of the Maglio Christopher & Toale Law Firm will be glad to review your medical records to determine whether we feel there are sufficient grounds for us to represent you in pursuing a case against the manufacturer. Click here for our online potential case evaluation form.

Typically in order to review a case, we need the orthopedic surgeon's office chart, the operative reports for the original joint replacement surgery and the revision surgery, and the device record for the original surgery from the hospital chart (this shows the product and lot numbers of the components of the device). We also like to have the device. Therefore, it is essential that you get possession of the device as soon as it is removed. It may still be possible to do the case with no device, but it will be much more difficult.