On May 22, 2018, Stryker Orthopedics updated its LFIT V40 Femoral Head Recall to include eight (8) additional catalog numbers. The original recall occurred in August 2016 and included seven (7) catalog numbers which represented close to 45,000 devices in commerce. The LFIT V40 is a femoral head that is utilized in hip replacement surgeries. According to the recall, Stryker has received a higher than expected number of femoral head/hip stem dissociations. Severe complications from the LFIT V40 Head include:
- Pain associated with implant loosening
- Peri-prosthetic fracture
- Revision to alleviate a hazardous situation
- Leg length discrepancy
- Loss of mobility secondary to hip/stem trunnion fracture or femoral head/hip stem dissociation
- Pain requiring revision surgery
- Inflammatory response
- Adverse local tissue reaction (ALTR)
The Stryker LFIT V40 is designed to offer a broad range of offsets based on the patients needs and can be used interchangeably with Stryker’s entire product line of modular total hip arthroplasty devices. Unfortunately, due to the potential corrosion at the head-neck junction, catastrophic dissociation and metallosis can occur and require emergent revision surgery.
The Unsafe Drug and Medical Device Team at Plymale Law are investigating the Stryker LFIT CoCr V40 femoral head cases on behalf of patients who were implanted with these devices and have suffered complications. In the event you receive any calls regarding these products, we welcome the opportunity to work with you and your clients.
Following several years of litigation, a Benicar settlement was announced by the makers of the popular blood pressure drug on August 1, 2017, offering financial compensation for certain individuals who experienced gastrointestinal problems, such as:
Sprue-like Enteropathy (“SLE”)
“Celiac-like” Enteropathy (“CLE”)
Nausea, Vomiting and Weight Loss
Misdiagnosis of Celiac Disease Continue reading
Serious Infections could have been caused by contaminated Triad Alcohol Wipes, Medical Pad, and other products
On January 3, 2011 The Triad Group issued recall of all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks after receiving complaints of potential contamination with an objectionable organism, Bacillus cereus. The recall came only after a 2-year-old toddler had died in December last after being infected with the Bacillus cereus, which resulted in multi-organ failure. Continue reading
Byetta Associated with Fatal Pancreatitis
Byetta (exenatide), an injectable type 2 diabetes drug marketed by Amylin Pharmaceuticals, Inc. and Eli Lilly & Company, was approved by the FDA in 2005 as an adjunct to diet and exercise to improve glycemic control. Byetta is not used for treatment of patients with type 1 diabetes. The FDA issued its first warning in 2007 about Byetta being associated with acute pancreatitis. Continue reading
Chantix May Increase Risk of Heart Attacks
Chantix (veranicline), manufactured by Pfizer, Inc., is a smoking cessation drug approved by the Food and Drug Administration (FDA) in 2006.
In 2009 in response to hundreds of reports the FDA required a “Black Box” warning to be added to Chantix side effects such as depression, suicidal thoughts, attempted suicide, and suicide. A Black Box warning is the strongest warning the FDA can impose on a drug, short of taking the drug off the market. Continue reading
Fosamax May Cause Osteonecrosis of the Jaw and Femur Fractures Continue reading
Levaquin causes tendon injuries and rupture Continue reading
Zoloft®, Paxil and other Selective Serotonin Reuptake Inhibitors (SSRIs) Linked to Birth Defects
Selective Serotonin Reuptake Inhibitors (SSRIs) include drugs like Zoloft®, Paxil, and Prozac that are generally used as antidepressants.
Recent studies have shown that using SSRIs while pregnant increases the risk of birth defects. These birth defects include, but are not limited to Persistent Pulmonary Hypertension (PPHN), heart, lung, abdominal and cranial defects. Continue reading
FDA Warns That Topamax May Cause Oral Cleft Birth Defects
On March 4, 2011, the Food and Drug Administration issued a warning that the drug Topamax, the brand name for topiramate, increases the risk of birth defects such as cleft lip and cleft palate in children born to women who take the drug while pregnant. Continue reading
Transvaginal Mesh Devices
The transvaginal mesh is a type of medical device used to treat Pelvic Organ Prolapse and Stress Urinary Incontinence, conditions that may occur after childbirth and pregnancy. The vaginal mesh products are manufactured by several companies, including Ethicon/Gynecare/Johnson & Johnson, C.R.Bard, Inc., Boston Scientific Corporation, American Medical Systems, and Caldera Medical.
Bard Avaulta Mesh vaginal sling product is marketed as the Avaulta Anterior and
Posterior Biosynthetic Support System.
Since 2005, more than 1,000 patients have suffered from serious complications following the placement of a transvaginal mesh device. Recipients of transvaginal mesh/sling products may suffer from complications, including: Continue reading