Revision Surgery
A revision surgery on an artificial joint is one in which a medical device implant has failed for some reason and needs to be replaced. This is a serious issue, as revision surgeries are almost always more significant than the original surgery, involve more blood and bone loss, a longer rehabilitation and recovery time, and a diminished likelihood of a successful outcome. The reasons for the knee or hip failure can be many, and are not always clear. The type of implant, the age and activity level of the patient, current symptoms or problems, and the original reason for the joint replacement are among the questions that need to be answered when determining the cause of a medical implant device failure.
However, regardless of the reason, a hip or knee joint simply should not fail in less than 8 years from the date of the original implantation. If this occurs, and a revision is required or recommended, there may be a defect or problem with the implant device. The implant may be defective.
If you or a loved one has had a revision surgery, or have been told by a doctor that one is recommended, and it has been less than 8 years after the hip, knee or other artificial joint was originally replaced, you may have a case against the manufacturers of the device for the product failure.
If this is the case, you should immediately contact the revision hip and revision knee attorneys at Keefe Bartels to review your medical information and help you determine if you have a case against the manufacturer of the implant device that had to be replaced. Contact our law firm if you believe you may have a defective hip or knee implant or orther defective medical devices, especially if you or your loved one have already undergone a revision surgery for an artificial knee, hip or other prosthetic joint.
Revision Hip Replacement
Hip replacement surgeries are one of the most common procedures performed by orthopedic surgeons. This procedure carries with it a very high success rate. However, if something does go wrong with the implant, a revision surgery on the hip may be required. In many cases, revision hip surgeries are a result of the prosthesis wearing out. The lifespan for an artificial hip can range from 10 years to over 30 years however; the end result is always the same; all hip implants will eventually wear out and require replacing. Common reasons for the implant wearing out can include a fractured or loosened implant, premature wear of the plastic components, infection, or a break in the supporting bone around the implant or other trauma.
Normal wear of a hip implant is expected, however it is important to recognize the difference between normal wear and a defective implant joint. Numerous hip implant products have come to light in litigation as being defective including products from major hip implant manufacturers such as Stryker, Zimmer, Centerpulse Orthopedics (formerly Sulzer Orthopedics), Smith & Nephew, and Howmedica. A revision surgery may be recommended for these defective hip implant products to remedy the failed medical device situation.
Centerpulse Orthopedics (Sulzer) Hip Implant Recall
There have been numerous issues with hip implant systems over the years. For example, in early 2001, Sulzer Orthopedics (now Centerpulse Orthopedics) issued a recall of its hip replacement products due to the growing number of adverse reports from doctors using the implant on patients. After a two month investigation, it was found that a small amount of lubricant residue was being left on the implant during the manufacturing process. This hip replacement product was meant to snap into place and for bone to actually grow into it. The lubricant residue left on the implant interfered with the bonding which caused the implant to fail and required some patients to have revision surgery to remedy the situation.
Femoral Head Recall
In late 2001, 8 hip implant manufacturing companies (Apex Surgical; Biomet, Inc.; DePuy Orthopaedics, Inc.; Encore Orthopedics, Inc.; Osteoimplant Technology Inc.; Smith & Nephew, Inc.; Stryker Howmedica Osteonics; and Zimmer, Inc.) issued recalls due to a problem with the zirconia ceramic femoral head component, which was manufactured by St. Gobain Desmarquest. This component (which connects the femoral stem to the pelvis) was fracturing at a higher rate than what was expected, as early as 13 to 27 months after the initial implantation. If the hip implant fractured in patients, serious injury including pain and suffering from the implant was caused and a revision surgery was necessary.
Stryker "Squeaky Hip" Warning Letter
In late 2007, Stryker's manufacturing facility in Mahwah, New Jersey was issued a warning letter from the FDA for manufacturing problems in conjunction with malfunctioning hip implant components. Some of these malfunctions led to device failure and required revision surgeries to repair the problem. In the letter, the FDA cited a number of complaints where patients describe an array of issues with the implants including squeaking noises, problems walking, and extreme pain and suffering. During an inspection in 2007, the FDA uncovered a litany of problems at Stryker's New Jersey facility including bacterial contamination. The FDA stated in the warning letter that the problems found at Stryker's manufacturing plant directly contributed to the failure of the defective hip products.
Click Here to Read More Detailed Information on FDA Hip Implant Recalls
Revision Knee Replacement
Knee replacement products also eventually wear to the point that a revision procedure may be necessary. Knee implants bear a large amount of weight anytime the patient is putting pressure on that limb. Over time, the mechanical components of the implant will wear down and require replacement. Other factors besides wear can also lead to a revision surgery of an artificial joint, including misalignment, loosening, failure of the device to bond to healthy bone, the presence of foreign material, and infection. Revision surgery on a knee implant is also substantially more risky than the initial knee implant surgery. All the risks that are associated with the original operation are present in a joint revision surgery; however, those risks are increased. There is also the risk that the revision operation can result in the patient having a shorter limb or less range of motion in the knee or other joint. The decision to have revision surgery on a knee implant can be very frustrating and difficult. This frustration and anger can grow by multiples if the knee replacement is defective from the manufacturer and forces the individual to have an additional operation due to manufacturer error.
Similar to defective hip replacement systems, there are also numerous issues that have come to light with knee implant products. Following are just some of the FDA or manufacturer recalls from major knee replacement manufacturers:
Smith & Nephew Knee Replacement Recall
In 2003, Smith & Nephew, a medical device company that sells its products worldwide, issued a recall of two of its knee replacement systems: Oxinium Genesis II and Profix II Knee Implants. The reason for the recall was a result of the failure of the knee replacement systems to bond properly. These knee replacement products recalled by Smith & Nephew caused patients to have an amplified amount of pain, infections, inflammation, and damage to muscles and joints. The failure of these knee implant systems led to patients requiring additional surgeries to replace the defective medical product which subjected patients to increased operation risks and lengthened the time for rehabilitation.
Four years later in late 2007, Smith & Nephew issued a precautionary recall to a number of its knee replacement systems including products from its TC-PLUS, VKS, and RT-PLUS knee ranges. A number of the implant castings were being constructed with a higher than specified iron content. Smith & Nephew also announced in that recall that it was going to carry out lab testing to determine if the implant's material properties or durability had been affected due to this error.
Sulzer Knee Implant Recall
In early 2001, Sulzer Orthopedics, currently Centerpulse Orthopedics, a Texas subsidiary of Sulzer Medica in Switzerland, announced a recall of its knee replacement products due to manufacturing error. The knee replacement systems were contaminated by a lubricant residue that was used during manufacturing. The residue inhibited the ability for the replacement to bond correctly to the surrounding bone when the knee implant was installed.
Stryker Knee Implant Warning
The MHRA (Medicines and Healthcare Products Regulatory Agency) released a warning in 2008 in regard to Stryker Orthopaedics Kinemax Plus Revision TS Tibial inserts. The document identified this Stryker product as having a risk of becoming loose and higher risk of fracturing due to manufacturer error. The warning also requested that all surgeons stop implanting the affected devices and return the defected knee implants to the manufacturer. Stryker issued a recall of this product line soon after.
Click Here to Read More Detailed Information on FDA Knee Implant Recalls
