August 7, 2001 - When Medical Devices Fail in the Body
A subsidiary of Sulzer Medical admits that it can no longer maintain its formerly expressed opinion that it is sufficiently insured to cover all the costs that will be associated with the recall of its allegedly defective Inter-Op hip implant.
Sulzer Orthopedics Inc., based in Austin, Texas recalled their product on December 5, 2000. The company's investigation into the problem reveals that a trace of mineral oil-based lubricant remaining on the implant after the manufacturing process was responsible for the lack of proper bonding between the implant and the bone, in some cases.
According to the lawsuit, over 17 500 hip implants were defective because the oil used in machining was not properly removed and the bones failed to bond to the implant. As a result, it is claimed, the implants eventually come loose causing severe groin pain and inability to bear weight among other problems. The implants, Sulzer's Inter-Op acetabular shell, were primarily sold after October 1999.
Sulzer has also focused on elements within the mineral oil-based lubricant. The company officials said it has put in place the manufacturing and cleaning steps necessary to prevent the problem from recurring.
To date the number of revision surgeries performed after the recall of the implant exceeds 1700. The company believes that most of the problems experienced by patients occurred within the first six months after receiving their implants. It believes that, based on revision data so far, the most critical period since implantation has passed. However, Sulzer does not want to commit itself to making a prediction on the final number of revision surgeries.
Sulzer is also testing its porous-coated tibial baseplate that was manufactured from July to December 2000. It has reported to the US Food and Drug Administration. It appears a few clinical incidences have been reported so far and investigations are non-conclusive. The affected porous-coated tibial baseplates, which are no longer on the market, were implanted in 1485 patients around the world. Of these, 1336 patients were in the USA, 97 were in Europe and 52 were in Australia.
Other Sulzer Orthopedics porous-coated products are not affected because they are produced using a different process and have reported successful clinical outcomes.
A Detroit firm, Charfoos & Christensen PC, filed a Motion for Class Certification in the Sulzer hip class-action lawsuit originally filed 6 March 2001. This case is the first Sulzer hip case filed in Michigan. A lawsuit was originally filed in Los Angeles, California.
To date, over 1 400 surgeries have been performed to replace the defective hip prostheses. Thousands of additional surgeries will have to be performed on those who received the defective hip implants.
The Michigan lawsuit was filed on behalf of Susan Jarrell and the class of people who also received these defective implants. Ms Jarrell underwent hip replacement surgery in June 2000. Other Michigan lawyers have also filed a class action lawsuit on behalf of Michigan residents who had hip replacement surgery after July 1997.
Since August 2001, 2,380 patients have undergone new surgery to replace defective Sulzer hips, and there a presently over 1,000 cases pending against Sulzer. If you or someone you know has had a hip replacement involving a defective Sulzer implant, it is important to seek medical and legal assistance as soon as possible. In all medical product liability cases it is essential that measures be taken promptly to preserve evidence, investigate the procedure in question, and to enable physicians or other expert witnesses to thoroughly evaluate any injuries. If you believe that you may be a victim of a defective hip implant, call now at or CLICK HERE TO SUBMIT A CASE FORM. The initial consultation is free of charge, and if we agree to accept your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. Don't delay! You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires.
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