Knee Replacement Recalls

FDA recall

Knee replacements are performed each year in over 1 million people, primarily for the diagnosis of osteoarthritis.  Increased life expectancy and an increase in conditions such as obesity, which contribute to arthritis have increased the demand for knee replacement surgery.

In addition to increased demand caused by an aging population, many of patients wish to remain active beyond retirement, meaning that they need reasonable mobility for a longer period of time.  This has required joint replacement manufacturers to attempt to design devices that are more flexible, stable, and that can last for much longer than previous devices.

While most knee replacement procedures are successful, thousands have resulted in severe injury to patients who receive them.  Hundreds of recalls have occurred regarding improperly designed devices and many of these patients have been forced to file lawsuits against manufactures of faulty devices.

Thousands of lawsuits have been filed against five of the largest medical device manufacturers, all of whom have been forced to issue multiple recalls regarding their faulty devices.  Manufactures such as DePuy Orthopedics, Zimmer Holdings, Biomet, Smith & Nephew, and Stryker Orthopedics are potentially facing lawsuits filed by patients who have experienced severe side effects and many more are expected.

Complications Caused by Knee Replacement Devices

Any type of surgery, including knee replacement procedures have some side effects.  Most patients experience only minor side effects including mild to moderate pain, swelling, and inflammation which will go away after a period of time.

In some cases however, patients experience side effects or adverse events that are more serious and warrant medical attention.  Some of these patients will require knee revision surgery.

Serious adverse events related to knee replacement surgery may include:

  • Debilitating pain or inflammation
  • Infection of the knee which may become body-wide
  • Nerve or blood vessel damage surrounding the knee device
  • Bone or joint tissue damage
  • Loosening of the replacement device, resulting in immobility
  • Lower leg blood clot development (deep vein thrombosis or DVT)

These serious adverse events may require the patient have a revision surgery or second surgery to remove and replace the original joint device.  Second surgeries are generally much more invasive, painful and will likely require a longer recovery period.

Knee Replacement Manufacturer Violations

In 2007, manufactures including DePuy, Zimmer, Biomet, and Smith and Nephew paid hundreds of millions of dollars in fines to settle charges of improper payments made to surgeons in exchange for using their devices.  Additionally, Stryker agreed to 18 months of federal supervision rather than pay the fines.

Biomet is set to be acquired by Zimmer Holdings in 2015 for $13.35 billion, however Biomet is currently facing accusations of the bribery of Mexican officials and until the charges are settled, the merger may not occur.  If the merger does take place, Zimmer will also assume responsibility for any lawsuits filed against Biomet in addition to lawsuits they are facing.

Knee Replacement Recalls

Over 700 recalls have been issued for knee devices manufactured by the five largest medical device companies.  Many of these devices have caused serious injuries and the companies may be facing lawsuits regarding the injuries.  Affected devices include:

Zimmer Holdings has issued well over 200 recalls for knee devices or components, mainly due to complaints about its “NexGen” knee series including:

  • NexGen MIS Tibial Components
  • NexGen TM Tibial Trays
  • NexGen LPS-Flex GSF Femoral Component
  • NexGen MIS Modular Tibial Plates and Keels
  • Natural-Knee II Durasel Patella

Zimmer will be the second largest orthopedics company in the US after completion of an expected acquisition of Biomet.  Zimmer previously acquired Sulzer Medica, which had manufactured the Natural-Knee II device.  Sulzer had previously paid over $1 billion to settle claims related to the knee implant and other devices.

Over 1000 lawsuits regarding Zimmer’s NexGen devices have been filed in federal courts but the company will likely face many more and will also likely be responsible for any Biomet lawsuits that result from faulty knee devices.

DePuy Orthopedics, a subsidiary of Johnson & Johnson has issued over 470 recalls regarding its knee devices or components including:

  • TruMatch Personalized Solutions
  • PFC Sigma Knee System with titanium components
  • PFC Sigma Knee System components, sizes 2.5, 7 and 8
  • PFC Sigma Knee System 30mm – 40mm thick inserts
  • Femoral heads that include a 14/16 taper
  • Femoral heads with offsets greater than +12
  • LPS Diapyseal Sleeve
  • LCS Duofix Femoral Component

Johnson & Johnson, the parent company of DePuy Orthopaedics is the largest medical and pharmaceutical products company in the world.  DePuy was also warned in 2010 by the Food and Drug Administration regarding accusations of marketing without approval, though one of these systems was subsequently approved and others were removed from the market.

Biomet had 75 recalls in the last decade for devices including:

  • Vanguard PS Open Box Femoral Component
  • Vanguard DCM PS Plus Tibial Bearing Implant
  • Vanguard CR
  • Biomet Surgical instruments

Biomet is expected to be acquired by Zimmer holdings, however pending accusations of the bribery of Mexican officials may delay the merger.  If the merger succeeds, Biomet and Zimmer will become the second largest orthopedics company in the U.S.

Stryker Orthopedics issued nearly 120 recalls for some of its implants such as:

  • ShapeMatch Cutting Guide
  • Duracon Total Knee
  • Unicompartmental Knee System
  • Scorpio PS and CR components

Smith & Nephew filed for 11 recalls in the last decade including recalls of:

  • Journey Uni Tibial Baseplate
  • Oxinium Genesis II and Profix II

Issues noted in recalls commonly included:

  • Sterility issues
  • Mislabeling issues including components and metal content
  • Missing components or features
  • Improper assembly guides
  • Faulty design of implant tools or manufacturing
  • Implant loosening
  • Other manufacturing issues

Implants are recalled because issues related to design or manufacturing may pose a significant risk to patients.  Any serious adverse event caused by a faulty knee replacement device may warrant an invasive knee revision surgery.

Knee Replacement Lawsuits

Many of the recalled devices have caused significant injury and required revision or additional replacement and reconstructive surgeries.  Thousands of lawsuits have already been filed and many more are expected in federal, state and local courts.

Patients who have experienced severe side effects may be eligible for monetary damages related to medical costs, lost wages and pain and suffering.  In some cases punitive damages may also be awarded.

Patients should not discuss details of their medical condition with manufacturer’s representatives before consulting with an attorney of their own.

Show Sources
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