October 26, 2014

Defective Knee Implant Recalls

Knee replacement surgery can give patients restored comfort and mobility. Unfortunately, defective knee implants are nothing new. There have been many recalls of knee implants systems and components over the years. Defective knee implants cause pain, lack of mobility, and require patients to undergo expensive and painful revision surgery to replace the defective device. Some patients are harmed to the extent that they are actually in far worse condition than if they had never had knee replacement surgery at all. If you have been injured by a defective knee implant our defective knee implant attorneys can help.

2001 DePuy and Sulzer Recalls

The Hylamer Polyethylene Bearing Surface was created to minimize wear in joint replacement components, extending their life. It was used in knee replacement as well as other joint replacement systems. DePuy withdrew the products from the market in the late 1990’s and in 2001, the British government Medical Devices Agency issued a recall of knee implant Hylamer liners sterilized with gamma radiation in air. It turned out that the gamma air radiation sterilization process weakens polyethylene. One study found that about two-thirds of the implants had failed within five years.

Also in 2001, Sulzer Orthopedics recalled knee implant systems which had been contaminated during the manufacturing process. The knee implants were contaminated with a lubricant which interfered with the implant’s ability to bond to bone.

2003 Smith & Nephew Oxinium Knee Implants

In 2003, Smith & Nephew notified the U.S. Food and Drug Administration (FDA) of a problem with its cementless Oxinium knee implants and issue a voluntary recall of the defective implants. The Oxinium Genesis II and Profix II knee implants did not bond properly with the bone and were coming loose. The recall was issued after about 30 U.S. patients required revision surgery. At the time of the recall about 3,000 people already had the Oxinium knee implants installed, and by February 2005, 782 of the defective knee implants had been replaced through revision surgery.

2004 Encore Knee Replacements

In 2004, Encore’s Foundation Knee System and 3DKnee System were recalled due to mislabeling. The Foundation products were labeled as 3DKnee and 3DKnee were labeled as Foundation.

2008 Multiple Knee Replacement Recalls

2008 was a big year for knee implant recalls, and included recalls of defective knee implants and defective instruments used during knee replacement procedures. 2008 recalls included:

DePuy LCS Knee, Meniscal bearing insert component marked with inaccurate size. The 10mm inserts were labeled and etched as 12.5mm inserts.

Smith & Nephew TC-PLUS, VKS, and RT-PLUS contained high than specified iron content.

Encore Foundation Knee System Tibial Fixed Impactor recalled after reports of a screw fracturing during surgery.

Encore 3DKnee Tibial Insert Trial marked incorrectly for thickness.

Zimmer NexGen Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor recalled because the instrument may fracture during use and leave metal fragments in the patient after surgery, which could cause the implant to fail.

Zimmer NexGen Complete Knee Solution articular surface insertion instrument recalled because it could fracture during use.

If you believe that you or a loved one has been injured by a knee implant or other medical device, please call or submit an online questionnaire. The initial consultation with one of our attorneys is free of charge, and if we agree to handle your case, in most cases we will work on a contingency fee basis, which means we get paid for our services only if there is a monetary recovery of funds. In many cases, a lawsuit must be filed before an applicable expiration date, known as a statute of limitations. Please call right away to ensure that you do not waive your right to possible compensation.