FAQ About Medical Devices

Notification of the Phillips Respironics defects was first released in April of 2021, followed by the recall in June.  The company is estimating that as many as 3-4 million devices sold before April of 2021, the majority of which are DreamStation models, may be subject to flaws that carry a significant risk of lung injury,… read more?

Following the emergence of a range of health complaints, MedTech company Phillips has issued a recall for several Respironics ventilators, including CPAP machines, bi-level positive airway pressure (BiPAP) machines, and mechanical ventilators. The recall list includes the following CPAP and BiPAP machines: Continuous Ventilator, Minimum Ventilatory Support, Facility Use E30 (emergency use authorization) Continuous Ventilator,… read more?

The notice sent to surgeons recommends against removing an Exactech device absent evidence of its failure as long as it functions properly and is not causing pain or discomfort to a recipient. The company advised physicians company to monitor patients who complain of any of the following symptoms: Knee or ankle instability.Weight-bearing issues.Noises, including grinding… read more?

Exactech claims it discovered (through testing) that polyethylene components used in the total ankle, hip, and knee replacement systems were packaged and stored in “non-conforming” vacuum bags. The purpose of the bags was to limit exposure of the polyethylene or plastic components while in storage to prevent deterioration due to exposure to oxygen. The company… read more?

Exactech identified the several devices it manufactured and sold from 2004 through 2022 as containing materials that may be defective and could cause them to fail. The following knee, ankle, and hip replacements are recalled: OPTETRAK Partial & Total Knee Replacements:All-polyethylene CR Tibial ComponentsAll-polyethylene PS Tibial ComponentsB-Series Ps Tibial InsertCC Tibial InsertsCR Tibial InsertsCR Slope… read more?

On February 2, 2017, Rexina Mize and her husband Minh Nguyen filed a lawsuit against Mentor Worldwide LLC; Johnson & Johnson; Ethicon, Inc. in the Superior Court of California County of Los Angeles for the following: NegligenceFailure to warn consumers about the dangers of the productManufacturing defectBreach of implied warranty, andLoss of consortium, or damages… read more?

Plastic surgeons familiar with breast implants may only detect about 30% of ruptures occurring in breast implants, while an MRI can detect around 80% or more of ruptures or leaks in implants. Symptoms of a leaking implant may include: Hard knots or lumps around the implant, surgical site, or armpitDeformity of the breastChange in shape… read more?

Patients with defective MemoryGel Silicone breast implants may experience chronic fatigue, muscle pain or weakness, memory loss or confusion, show symptoms of silicone toxicity and/or other implant-related illness. Your plastic surgeon may want to remove or replace the implants if this occurs. If you’ve experienced health complications or needed to have your breast implants changed… read more?

Additionally, taper lock failures have been reported with LFIT Anatomic CoCR V40 Femoral heads. The following implants manufactured before 2011 are included: Item NumberHead DiameterOffset6260-9-23636 mm+56360-9-24040 mm+46360-9-24444 mm+46360-9-34040 mm+86360-9-34444 mm+86360-9-44040 mm+126360-9-44444 mm+12 read more?

Side effects of the taper lock failures may include: Severe painDamaged tissuesurrounding the hipDislocationInflammationMobility lossRevision surgery to replace the faulty implant Similar injuries including metallosis and dissociation have been reported with the Stryker LFIT V40 hip replacement device. An MDL, or Multidistrict Litigation, consolidates similar cases throughout the country that involve the same product. The… read more?

Hip replacements are one of the most common implant procedures performed in the United States and an estimated 250,000 replacements are performed each year. A hip joint is a type of “ball and socket” joint and a total hip replacement involves replacing both these parts at the same time. The materials used in an artificial… read more?

Other problems that can develop from metal-on-metal hip implants include: Loosening of the product from the boneSwelling and inflammationDecreased mobility due to difficulty walkingBone around the implant may breakDislocation of the implanted joint and attached bones because parts of the implant that move against each other are no longer aligned On July 24, 2008, Zimmer… read more?

A hernia occurs when an organ bulges through weakened tissue or abdominal opening, and it can be caused by a number of different things. These ruptures often develop after surgery, where the tissue is in a weakened state and susceptible to damage. Hernias may occur in the abdomen, upper thigh, groin, and/or belly button, and… read more?

Surgical mesh is a medical device attached to the weakened tissue, or hernia, to provide support and prevent the organ from continuing to push through the wall. Three different types of mesh may be used for hernia repair: Synthetic, which is generally made of polyester and polypropylene.Biologic, which is made of biological material such as… read more?

Manufactured by Ethicon, the Physiomesh product was cleared through the FDA 510(K) approval process in 2010. The FDA 510(K) approval process is used when a product is modeled after a device that has been fully approved by the FDA, and it requires less testing than the FDA requires for new medical devices on the market.… read more?