medical malpractice

It is well known that hip pain and other symptoms are greatly improved once a patient undergoes revision surgery to remove metal-on-metal hip implants like the Stryker Rejuvenate or ABGII hip implant. However, no one has ever has ever examined how quickly elevated cobalt and chromium levels go down after revision. The Rejuvenate and ABGII femoral stems are made of a proprietary titanium alloy with a cobalt-chromium modular neck. It is suggested that the mixed metals are more susceptible to corrosion and fretting which is why doctors routinely monitor metal ion levels and inflammatory blood markers. We know that metal ion levels and inflammatory markers increase prior to revision due to fretting and corrosion.   Barlow and his colleagues evaluated the pre- and post-operative metal ion levels and the inflammatory markers of patients revised due to pain and adverse reaction to metal. They found that both cobalt and chromium levels as well as the inflammatory blood markers came down at 6 weeks following revision surgery, with cobalt and chromium at near normal levels at 6 months.

See Barlow, B.  et al. (2015). Short-term metal ion trends following removal of recalled modular neck femoral stems, Journal of Arthroplasty, Epub

Weisman, Kennedy and Berris is currently serving on the leadership of national litigation involving DePuy’s ASR and Stryker’s Rejuvenate and ABGII devices. The firm has extensive experience in handling lawsuits against orthopedic device manufacturers and has been extremely successful in obtaining just compensation for clients from across the country for  pain, suffering and lost wages resulting from failed implants. If you or someone you know has experienced such a failure, attorneys at Weisman Kennedy and Berris would be happy to answer any questions you might have about available rights.

There has been a lot of literature recently concerning hip implant failures due to fretting and corrosion at the neck/stem interface. What does this mean for the patient? It means pain, swelling,  instability and limited mobility. Kent et al conducted study of the K2/Apex uncemented femoral stem, a hip implant composed of cobalt-chromium and titanium, similar to the Stryker Rejuvenate and ABGII.  Metallosis and other adverse tissue reactions caused by fretting and corrosion from this mixed metal coupling were reported as the second most common reason for revision. Stem stability was also analyzed demonstrating significant movement against the femur (thigh bone).  This stem movement can inhibit bony ingrowth and lead to loosening and increased revision risk.

See Kent, M. et al. Stem migration and fretting corrosion of the anti-rotation pin in the K2/Apex hip system, The Journal of Arthroplasty, 2015

Weisman, Kennedy and Berris is currently serving on the leadership of national litigation involving DePuy’s ASR and Stryker’s Rejuvenate and ABGII devices. The firm has extensive experience in handling lawsuits against orthopedic device manufacturers and has been extremely successful in obtaining just compensation for clients from across the country for pain, suffering and lost wages resulting from failed implants.  If you or someone you know has experienced such a failure, attorneys at Weisman Kennedy and Berris would be happy to answer any questions you might have about available rights.

Are you suffering after your hip implant revision surgery? A high percentage of patients implanted with monoblock metal-on-metal (MoM) total hip implants like the DePuy ASR suffer from early complications after revision surgery. Louis Stryker, M.D. and his colleagues understand that the reasons metal-on-metal hip implants fail are quite unique compared to conventional hip replacements. These include metallosis and other adverse tissue reactions. Because of the distinct failure mode of metal-on-metal devices, Dr. Stryker et al.  reviewed potential complications following revision.  The implants they investigated were from Biomet, DePuy, Wright Medical and Zimmer. The complications they found included aseptic loosening, deep infection, dislocation, acetabular fracture, superficial infection, infected hematoma, hematoma and delayed wound healing.  They found that older patients are at an increased risk for early complications after revisions while there were no particular differences in sex or time between implant and revision surgery. If you or a loved one have been implanted with one of these devices and have undergone a revision surgery, please contact one of the attorneys at Weisman, Kennedy & Berris to discuss your case.

See Stryker, L. et al. Revisions of Monoblock Metal-on-metal THAs Have High Early Complication Rates, Clinical Orthopedics and Related Research, 473, 469-74

Weisman, Kennedy and Berris is currently serving on the leadership of national litigation involving DePuy’s ASR and Stryker’s Rejuvenate and ABGII devices. The firm has extensive experience in handling lawsuits against orthopedic device manufacturers and has been extremely successful in obtaining just compensation for clients from across the country for pain, suffering and lost wages resulting from failed implants. If you or someone you know has experienced such a failure, attorneys at Weisman Kennedy and Berris would be happy to answer any questions you might have about available rights.

Ever wonder how surgeons choose the right hip implant to use during surgery? There is a huge range of possible prosthesis combinations available for orthopedic surgeons to choose when they perform total hip arthroplasties. In 2000, the National Institute for Health and Care Excellence (NICE) established a 10 year revision rate benchmark of 10% for all hip  implants, meaning it was OK if 10% of a specific hip implant device was revised within 10 years. Due to the catastrophic failures and subsequent voluntary recalls of devices like the DePuy ASR, Stryker Rejuvenate and ABGII , NICE recently determined that this international benchmark for revision rates must be revisited so that poorly performing devices can be phased out. The authors of this study retrospectively reviewed the National Joint Registry of England and Wales to compare the 10 year revision rates for the most frequently used types of hip implants and prosthesis combinations. They found that all of the revision rates were less than 5% and supported NICE’s reduction of the international revision rate guideline from 10% to 5%. These authors also found that the regulation of new devices should be considered a priority as loose regulatory mechanisms have allowed a very large number of hip device brands to come into routine use without strict monitoring.

See Kandala, N-B et al. Setting benchmark revision rates for total hip replacement: analysis of registry evidence, BMJ, March 9, 2015

Weisman, Kennedy and Berris is currently serving on the leadership of national litigation involving DePuy’s ASR and Stryker’s Rejuvenate and ABGII devices. The firm has extensive experience in handling lawsuits against orthopedic device manufacturers and has been extremely successful in obtaining just compensation from clients across the country for pain, suffering and lost wages resulting from failed implants. If you or someone you know has experienced such a failure, attorneys at Weisman Kennedy and Berris would be happy to answer any questions you might have about available rights.

Despite the advantages of an additional level of modularity at the femoral neck there continues to be reports of clinical concerns of corrosion, metallosis and fracture of the modular neck in dual modular devices. The Stryker Rejuvenate, a dual modular hip implant, was voluntarily recalled in 2012 because of high revision rates. The authors of this study analyzed several Stryker Rejuvenate devices to determine why the implants failed.  Patients in the study underwent relatively early revisions as all devices had been implanted for an average of 1 ½ years before being removed. Cobalt, chromium and titanium metal ion levels were measured and all were relatively low, despite metallosis and soft tissue destruction findings in many of the patients. In this study the most severe damage from corrosion was seen at the neck/stem interface, the area of greatest stress according to Finite Element Analysis. Finite element analysis is a computerized method that shows whether a product will break, wear out, or work the way it was designed. This study confirms what other studies have also found, that the area of most severe corrosion corresponds to the area that has the greatest stress, making the stem aspect of a modular neck/stem junction at increased risk of corrosion.

See Lanting, Brent et al. Correlation of Corrosion and Biomechanics in the Retrieval of a Single Modular Neck Total Hip Arthroplasty Design Modular Neck Total Hip Arthroplasty System, Journal of Arthroplasty, 30, 135-140

Weisman, Kennedy and Berris is currently serving on the leadership of national litigation involving DePuy’s ASR and Stryker’s Rejuvenate and ABGII devices.  The firm has extensive experience in handling lawsuits against orthopedic device manufacturers and has been extremely successful in obtaining just compensation from clients from across the country for pain, suffering and lost wages resulting from failed implants. If you or someone you know has experienced such a failure, attorneys at Weisman Kennedy and Berris would be happy to answer any questions you might have about available rights.

Muscle atrophy is a well-known complication from metal-on-metal hip implants.  A recent article discussed changes in soft tissue seen on MRIs over time with patients implanted with metal-on-metal modular stemmed prostheses and hip resurfacings. The median implantation time was 7 years. The authors described the muscle atrophy and pseudotumor formation that develops as part of the inflammatory response to metal wear debris and concluded that both worsen over time. This information could assist doctors with management of their patients with THAs to consider earlier revision surgery to prevent permanent muscle destruction.

See Berber, R. et al. Muscle atrophy and metal-on-metal hip implants, Acta Orthopaedica, 86, 351-357 (2015)

Weisman, Kennedy and Berris is currently serving on the leadership of national litigation involving DePuy’s ASR and Stryker’s Rejuvenate and ABGII devices. The firm has extensive experience in handling lawsuits against orthopedic device manufacturers and has been extremely successful in obtaining just compensation for pain, suffering and lost wages of clients from across the country resulting from failed implants. If you or someone you know has experienced such a failure, attorneys at Weisman Kennedy and Berris would be happy to answer any questions you might have about available rights.

Ultrasound and MRI are the primary imaging techniques used to detect pseudotumors and other soft tissue pathology in patients with metal-on-metal THAs.  Soft tissue lesions can be difficult to detect because patients can have symptoms, such as pain and discomfort and elevated cobalt and chromium levels, or no symptoms at all. There have been several studies comparing the efficacy of the relatively low cost ultrasound with the higher cost MRI but none have compared ultrasound to actual revision surgery findings. The authors of this article described the prevalence and type of pseudotumors detected with pre-revision ultrasound and compared it to revision surgery findings. They concluded that the presence of pseudotumors is well detected with ultrasound but there is a discrepancy with intraoperative findings at revision.

See Lainiala, O. et al. Good sensitivity and specificity of ultrasound for detecting pseudotumors in 83 failed metal-on-metal hip replacements, Acta Orthopaedica, 86, Epub, (2015)

Weisman, Kennedy and Berris is currently serving on the leadership of national litigation involving DePuy’s ASR and Stryker’s Rejuvenate and ABGII devices. The firm has extensive experience in handling lawsuits against orthopedic device manufacturers and has been extremely successful in obtaining just compensation for pain, suffering and lost wages of clients from across the country resulting from failed implants. If you or someone you know has experienced such a failure, attorneys at Weisman Kennedy and Berris would be happy to answer any questions you might have about available rights.

Dr. Sutphen and colleagues from Columbus, OH  conducted a retrospective study with patients who had been implanted with the metal-on-metal Zimmer Durom hip implant.   They were trying to quantify the prevalence of pseudotumors in patients who underwent metal-on-metal total hip arthroplasties.  The study included only patients who required a total hip replacement due to osteoarthritis and subsequently consented to cobalt and chromium testing and MARS-MRI evaluation at their 3 year follow-up appointment.  The authors classified patients as either symptomatic (hip pain with activity)  or asymptomatic (no hip pain with activity). Their findings showed that clinical symptoms, such as metal ion levels and pain may not always correlate with the presence of a pseudotumor and that an increasing number of asymptomatic patients develop them as well. They felt that the use of standard follow-up evaluations (x-rays and clinical exam) underestimated the incidence of pseudotumors in an asymptomatic patient.

The law firm of Weisman, Kennedy & Berris is currently handling metal-on-metal cases involving the DePuy ASR hip implant. If you or someone you know, has been implanted with a DePuy ASR or Stryker Rejuvenate or ABG II hip implant please contact our office.

Cite Sutphen, S.A. et al. (2015). Prevalence of pseudotumors in patients after metal-on-metal hip arthroplasty evaluated with metal ion analysis and MARS-MRI, Journal of Arthroplasty, Epub

The authors of this article investigated Rejuvenate hip implant failures in order to identify patients who are at particularly high risk for developing adverse tissue reactions (ALTR). They also wanted to determine how accurate MRI and metal ion levels are in detecting ALTR. The results confirmed that females and small Rejuvenate stem sizes were at a higher risk of early failure as a result of a symptomatic pseudotumor within 3 years of follow-up. No one can seem to explain however, why some people with low cobalt-chromium levels and no pseudotumors develop symptoms, while some patients with high metal levels and pseudotumors remain asymptomatic.  The authors found that cobalt and chromium levels were not as accurate in identifying ALTR as MRI. Dr. Ghanem and his colleagues felt that the potential for developing complications with dual modular stems, such as the Rejuvenate outweighs their benefits.

Ghanem, E. et al. (2015). Corrosion and Adverse Local Tissue Reaction in One Type of Modular Neck Stem, Journal of Arthroplasty, Epub

An article by Dr. Johannes Cip and his colleagues recounts the reintroduction of Metal on Metal orthopedic devices and the injuries resulting from the byproducts of their wear and corrosion.  Although the authors found a consistent decrease in Blood Cobalt and Chromium following removal of the devices, they also noted increased rates of complications following these removal surgeries.  While the authors noted that early intervention was helpful to the patients’ prognoses, they observed an inexactness in determining implant failure.  According to their study, there can be a poor correlation between preoperative testing (blood and radiologic) and intraoperative findings or post-operative complications.  The authors also identified patients with pseudotumors and metallosis who were reportedly asymptomatic.   See Cip, J. et al. (2015). Revision of Articular Surface Replacement (ASR) Total Hip Arthroplasty: Correlation of Perioperative Data and Early Post-Revision Outcome Results, Journal of Arthroplasty, Epub (2015).

Weisman, Kennedy and Berris is currently serving on the leadership of national litigation involving DePuy’s ASR and Stryker’s Rejuvenate and ABGII devices.  The firm has extensive experience in handling lawsuits against orthopedic device manufacturers and has been extremely successful in obtaining just compensation for clients from across the country for pain, suffering and lost wages resulting from failed implants.  The firm is also actively investigating claims of individuals who experienced complications from the recalled Zimmer Persona knee prosthesis.  If you or someone you know has experienced an orthopedic device failure, attorneys at Weisman Kennedy and Berris would be happy to answer any questions you might have about available rights.