Hip Replacement Class Action Lawsuit
Stryker Hip Replacement Recall
A typical hip replacement is a one-piece implant system that features a neck and stem known as a monoblock. Both Stryker’s Rejuvenate and ABG II products were designed as a series of necks and stems that could be fitted together to better match a patient’s particular anatomy and physiology.
The Rejuvenate modular-neck stem was approved by the FDA June of 2008. This model was developed to closely mimic the biomechanics and anatomy of the human hip while providing enhanced stability for the patient, and making the implementation quite easier for the physician due to its flexibility.
The ABG II modular-neck stem device became approved by the FDA in November of 2009. Both the Rejuvenate and ABG II were marketed to younger patients as well as advertised as “high-performance”. Claims were made that each new hip replacement system were supposed to resist corrosion and metal fatigue which in theory would make them last longer. Their neck components are made from cobalt and chromium, and the stems have a titanium coating. Unfortunately, this means they can shed metal debris into the body upon wearing against each other causing further complications.
In 2012, Stryker voluntarily issued a recall for both the Rejuvenate Modular and ABG II Modular-Neck Hip Stems. All sales were and production were halted worldwide. Stryker is facing an increasingly high number of lawsuits filed by or on behalf of patients that received the recalled hip replacements.
In February of 2012, just three months prior to the recall, Stryker issued an “Urgent Field Safety Notice” to all implant surgeons and hospital risk managers that indicated the potential health hazards they had discovered about the two products. It was mentioned that the side effects included corrosion, fretting, and an increased rate of Adverse Local Tissue Reaction (ALTR) which resulted in inflamed tissue around the implant.
In April of 2012, a second “Urgent Field Safety Notice” was issued that stated “excessive metal debris and/or ion generation” cause by “fretting and/or corrasion at or about the modular neck junction” that “may lead to increased metal ion generation in the surrounding joint space.”
Treatment and Trauma
Unfortunately, the treatment required to correct a failed Rejuvenate or AGB II hip is often a complicated revision surgery. During this process, the entire femoral stem is removed and replaced with another, larger metal stem. Due to the stem being installed into the center of the femur bone, removing it is quite traumatic and often results in fractures to the femur itself. If fractures occur, more metal hardware will be installed to repair the femur. In the end, you’ll face a long and complicated recovery process, and potentially face permanent loss of hip function.
Hip Replacement Complications include:
- Blood toxicity from metal debris
- Malalignment and loose components
- Metallosis (corrosion and fretting)
- Tissue death in surrounding area (Necrosis)
- Bone loss (Osteolysis)
- Revision surgery required due to server pain and local reaction
- Additional surgery
LFIT V40 Femoral Head Recall
In Australia during the month of September in 2016, health authorities issued an alert that highlighted the risk of potential injuries related to the Stryker LFIT V40 Femoral Head Hip Implant. A number of dangers were posed included the elevated risk of component failure resulting in further injuries.
No less than a month prior in August 2016, Stryker Orthopedics issued a recall on the LFIT V40 series of femoral heads. This recall with specific to all LFIT V40 components that were produced prior to 2011. These particular femoral heads were used most commonly in conjunction with the Accolade stem and continue to show a high rate of failure. These failures have generated injuries including pain, join instability, loss of mobility, localized inflammation, dislocation, local tissue reaction, possible broken bones and even cause discrepancies in leg length. Because of these failures, patients are required to undergo painful, complex revision surgery.
Smith & Nephew Birmingham Hip Resurfacing
The BHR System was recalled in June of 2015 stemming form various studies that showed how the device was causing a high-rate of complications that required revision surgery in patients. This system is a metal on metal hip implant used on patients needing a partial hip resurfacing. The BHR implant has a spherical metal cap on the femur bone and a metal cup installed within the hip socket and was implanted in patients from 2006 through 2015.
BHR System reported adverse effects including:
- Revision surgery
- Chronic pain
DePuy Hip Replacement Recall
DePuy Orthopaedics and Johnson & Johnson issued a recall in 2010 for the following hip replacement systems:
- ASR™ XL Acetabular System
- ASR™ Hip Resurfacing System
Additionally, DePuy Orthopaedics discontinued but not recalled, their Pinnacle hip implant system which was found to be discharging metal particles into a patient’s bloodstream, in mid-2013.
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