What are the Design Flaws in Stryker Hip Systems?

The Stryker Howmedica Osteonics Corporation is a major manufacturer of orthopedic and medical devices including hip implants. Nearly a decade ago, the company began marketing its Rejuvenate, ABG II Modular-Implant Stem and Stryker LFIT Anatomic V40 devices for young and old patients touting the products’ durability and long-lasting designs. Unfortunately, the Stryker implant products have had significant issues where many patients have lost much of their range of motion and flexibility of the hip joint in the weeks and months after it was implanted.

The defective hip implant injury attorneys at Rosenfeld Injury Lawyers LLC provided the facts posted below to assist families in making a better-informed decision when seeking justice and taking legal action to obtain the compensation they deserve for their Stryker implant-related injuries.

The Food and Drug Administration (FDA) initially approved the first Stryker hip devices in 2008 through expedited 510(k) Premarket Notification Processes. The expedited process bypasses the more difficult approval method that requires extensive clinical trials and rigorous testing because their products were “substantially similar” to other FDA approved devices.

Unfortunately, sidestepping clinical trials can be extremely problematic if there is a defect in the design or flaws in the manufacturing process that is not identified until the device reaches the public. Since the initial launch of its popular hip implant devices, thousands of injured patients have filed lawsuits and compensation claims stating that defects in the implant units caused their injuries.

In 2012, Stryker Howmedica Osteonics voluntarily recalled all Rejuvenate units and ABG II Modular-Hip Stems Devices over serious concerns identified by the FDA. Sadly, the adverse side effects of selling these products with designed flaws still plague many men and women who underwent surgical procedures and still have the implant devices.

Stryker designed their products while attempting to avoid known problems concerning metal-on-metal implant devices by creating partial metal components using “mono-block” construction. Unfortunately, the products are manufactured with chromium and cobalt in their device necks and coat the neck-stems in titanium. The designers chose these materials due to their corrosion resistant properties.

Both Rejuvenate and ABG II are manufactured without a traditional ball-and-socket design. Instead, designers built the multiple stem and neck devices using separate pieces, so the surgeon could customize the device to meet the patient’s needs.

However, fretting occurs when the metals grind against each other when the joint moves, that erodes the surfaces and causes corrosion. Additionally, the products are known to release highly toxic metal shards, shavings, and particles into the tissue that surrounds the implanted device.

Nearly all the medical implants have the potential to cause significant, painful and life-threatening side effects. Unfortunately, the implants designed by Stryker have produced higher than expected failure rates that lead to ALTR (adverse local tissue reaction) that can ultimately result in more serious injuries and the need for revision surgery. The most common complications and side effects experienced by patients who still have a recalled Stryker implant include:

• • Intense pain experienced in the implant area, groin, and abdomen

• • Toxic metallosis (metal poisoning) caused by joint movement grinding that releases fragments and generates metal ions

• • Widespread inflammation caused by metal particles traveling through the bloodstream

• • A lack of hip stability

• • Clicking, popping, squeaking, or grinding sounds from the hip joint

• • Reduced mobility and limited range of motion

• • Difficulty walking or standing

• • Hip dislocation

• • Life-threatening infection

• • Headaches

• • Fatigue

• • Rash

• • Hip joint swelling

• • Pseudotumor (fake tumors) developing around the joint

• • Immobility-induced muscle atrophy

• • Osteolysis (necrotic (dead) bone tissue) dissolution

• Bone fractures and weakening bones surrounding the affected joint

The Stryker Corporation recalled their hip implant devices after they were linked to severe injuries and complications including metal toxicity exposure. The initial report showed elevated levels of metal toxins in many patients who had intense pain, severe allergic reactions, bone and tissue death, tissue inflammation and metallosis. Also, the release of cobalt and chromium particles into the bloodstream causes severe adverse effects including heart issues, neurological issues, blindness, and thyroid imbalance. Additional problems were caused by the release of metal ions that produce systemic damage that affects the lymph nodes, kidneys, liver, and spleen.

Metal poisoning is a significant worrisome condition that often does not present itself until after seemingly mild symptoms have caused substantial damage to the body. Unfortunately, many patients who underwent hip replacement surgical procedures are unaware that their implant was a recalled Stryker device.

Surgeons often recommend the patient undergo a revision or reconstructive surgical procedure when the bone tissue around the joint fractures or weakens. However, cost of the surgery is enormous, the procedure is highly invasive, and patients in recovery often experience intense pain. Additionally, the length of time required for rehabilitation and recovery is significantly longer than the initial surgical procedure when the Stryker device was implanted.

In 2015, nearly 17,000 Stryker orthopedic implants were recalled from the medical marketplace after the government discovered the products were sold with flawed packaging. The FDA initiated the recall notice on five artificial joint devices manufactured by Stryker Howmedica Osteonics. The federal agency identified the recall as a Class II Designated Recall where “a situation in which use of or exposure to a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

The Food and Drug Administration initiated the recall “because packaging integrity (a sterile barrier) of the packaging type KITS I may potentially be compromised by transportation.” Stryker notified many consumers that a recall had been initiated. This notice included an Urgent Medical Device Removal Letter/Acknowledgment Response Form.”

In May 2018, the Stryker Corporation issued another “Product Safety Notification.” This alert notified patients who still have a Stryker hip implant. The company stated that they had received a “higher than expected number of complaints” involving some of their implant devices.

The notification involved hip stems/femoral head dissociation. The new alert expanded the 2016 voluntary recall affecting more than 42,000 patients who’d undergone surgical procedures using an LFIT V40 Metal Femoral Head Hip Implant. At that time, Stryker had notified surgeons that their patients were experiencing “higher than expected” revision procedure rates caused by the failure of the devices’ taper lock. During these recalls and notifications, the Stryker Corporation recommended that patients who received a recalled hip implant device should undergo testing conducted by their surgeon and ask their doctor for advice on how to proceed.

If your doctor recently diagnosed your condition as severe due to the complications associated with the Stryker device, you likely need revision surgery to correct the problem. Unfortunately, revision surgical procedures often produce potential medical complications. You will probably need monetary compensation to recover your medical expenses, and recoup lost time away from work, the loss of future earnings and payment for your temporary or permanent disability.

While you might believe you have a clear case of liability against the manufacturer for designing and marketing a defective product, taking legal action can be difficult. Our law firm will listen to your story about what happened, what you are feeling, what you need, your financial burden and what it will take to overcome the pain and suffering you have endured after receiving your Stryker hip implant device.