Zimmer hip implant manufacturing subject to FDA action

Zimmer Holdings Inc. has a documented history of releasing flawed hip replacement implants onto the U.S. market. Two of its products, the Zimmer M/L Taper Prosthesis and the Zimmer Durom Acetabular Component, have been linked to health problems and the need for additional surgeries in some patients.

According to the FDA notice, the Zimmer devices were recalled due to higher-than-expected levels of manufacturing residues resulting from a process monitoring failure. The built-up residues can cause serious health problems for patients implanted with the device, including allergic reactions, pain, infections, and death. Patients exposed to the contaminated implant components may need to undergo revision surgery to fix the hip replacement system, which can be very costly and painful.

On August 28, 2018, Zimmer Biomet received a warning letter from the U.S. Food and Drug Administration (FDA) about quality violations found at a plant in Warsaw, Indiana. The agency had flagged the issues after a 2016 inspection of the site, but found in a re-inspection earlier this year that the company’s resolution was not up to par.

The FDA inspected Zimmer Biomet’s North Campus manufacturing site in Warsaw in the fall of 2016, serving up a 58-page Form 483 that listed 14 violations. The device maker responded in kind with its own lengthy document detailing how it would address the issues. But those efforts appear to have fallen short, as the FDA issued a second Form 483 with 11 observations after its re-inspection in April. The full list of observations made in the Form 483 include:

 

  • Failure to adequately establish procedures for corrective and preventive action for nonconforming products (a repeat observation the FDA noted having seen during 2011, 2012, 2013, 2014 and 2015 inspections).
  • Failure to adequately establish procedures to control product that does not conform to specified requirements.
    • Failure to create device packaging or shipping containers designed and constructed to proceed the device from alteration or damage during processing, storage, handling and distribution (a repeat observation noted during a 2015 inspection).
    • Failure to adequately establish procedures for monitoring and control of process parameters for a validated process.
    • Failure to adequately validate quality system software for its intended use according to an established protocol.
    • Failure to adequately establish procedures to ensure equipment is routinely calibrated (a repeat observation noted during a 2015 inspection).
    • Failure to adequately establish procedures for receiving, reviewing and evaluating complaints by a formally designated unit (a repeat observation noted during a 2015 inspection).
    • Failure to implement written MDR procedures (a repeat observation noted during a 2015 inspection).
    • The April inspection was a follow-up visit after a November 2016 FDA inspection identified quality and manufacturing systems issues to be addressed after Zimmer acquired and integrated competitor Biomet.
    • The company followed that inspection with its own internal audit and remediation plan.
    • Company officials acknowledged in June that “more work is required and needs to be completed to create and sustain the robust quality system we are committed to establishing.”
    • The most recent FDA inspection found instances when workers or processes didn’t follow what are considered “current good manufacturing practice requirements of the Quality System regulation.”
    • The FDA’s website says the manufacturing requirements assure product quality. “This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories,” the FDA states. “This formal system of controls … helps to prevent instances of contamination, mix-ups, deviations, failures and errors.”
    • The FDA website also say the requirements are flexible to allow manufacturers leeway in choosing “scientifically sound design, processing methods and testing procedures.”
    • The letter, disclosed Friday in an SEC filing, regarded “observed non-conformities with current good manufacturing practice requirements of the Quality System regulation” at the company’s North Campus facility.
    • “While the Warning Letter acknowledges our quality remediation plan and actions we’ve already taken to address the FDA’s inspectional observations, it notes violations that require additional action or explanation,” Zimmer Biomet said in the SEC filing.
    • Zimmer Biomet is working on a response to the letter and plans to send it within 15 business days of receipt. The company expects to meet with the FDA to discuss proposed corrections after it’s sent its response.
    • However, the warning letter does not require Zimmer Biomet to pull any products from the market, nor does it restrict the production or shipment of devices from the North Campus plant. It doesn’t affect the company’s ability to seek 510(k) clearance for devices, but premarket approval applications will be on hold until the problems have been corrected. While Zimmer Biomet doesn’t have any PMA applications before the FDA, future applications could be delayed if the issue drags on.
    • “We believe that the FDA’s concerns set forth in the Warning Letter can be resolved without a material impact to our financial results. We cannot, however, give any assurances that the FDA will be satisfied with our response to the Warning Letter or as to the expected date of the resolution of the matters included in the Warning Letter,” the company said in the SEC filing. “Until the issues cited in the Warning Letter are resolved to the FDA’s satisfaction, the FDA may initiate additional regulatory action without further notice. Any adverse regulatory action, depending on its magnitude, may restrict us from effectively manufacturing, marketing and selling our products and could have a material adverse effect on our business, financial condition and results of operations.”
    • FDA Warning About the Zimmer M/L Taper Prosthesis With Kinectiv Technology
    • The FDA has issued a Class I recall of a Zimmer hip implant component used in hip replacement systems. The M/L Taper with Kinectiv Technology Femoral Stems and Necks is a Tivanium alloy device is used by surgeons to fit hip replacement systems to individual patients.
    • Zimmer Holdings Inc. was targeted by the FDA as several reports of adverse events and complications related to the NexGen Flex Knee and Durom Cup were noted. In September and December 2010, many implants were recalled. In March 2015, there was a recall for Persona Trabecular Metal Tibial Plate by the FDA.
    • The Zimmer Kinectiv Prosthesis was marketed as a way for surgeons to custom fit the hip implant to the patient’s anatomy. Surgeons can remove damaged portions of the hip joint and replace them with Zimmer’s integrated hip system, including an artificial femoral stem and neck. But in the years after the device was approved by the FDA, the department received reports of corrosion between the neck and stem, causing harmful side effects.
    • The corrosion was only one problem caused by the device. In 2015, the FDA issued a Class I recall due to higher than expected levels of manufacturing residues in the Zimmer M/L Taper. Failure to monitor the manufacture of the implants led to industrial residues left on the implant, which were then inserted into patients. Patients who received the implant have suffered:

 

  • Pain and inflammation. Patients may suffer swelling, redness, and irritation at the implant site, which may develop into infection of the bone and tissues surrounding the implant. If infection cannot be controlled with antibiotics, the device may have to be removed.
  • Tiny particles of metal are released into the body as the pieces of the implant grind together, resulting in metal poisoning (metallosis). As these particles enter the bloodstream, they can cause serious complications throughout the body, including bone degeneration and damage to the nervous system.
  • The breakdown of bone tissues due to metallosis greatly increases the risk of fractures, both in the hip joint and elsewhere in the body. These fractures can cause the device to dislocate and can make implantation of a replacement device much more difficult. Risk of fracture is even higher for post-menopausal women, potentially affecting these patients’ mobility for the rest of their lives.
  • Allergic reactions. In 2015, the FDA alerted consumers and hospitals about reports of industrial residues left on the Zimmer M/L Taper during the manufacturing process. The company’s failure to monitor its product caused patients to suffer allergic responses, including pain and irritation due to metal poisoning, and led to a Class I recall of the affected devices.
  • Revision surgeries. Metallosis, allergic reaction, loosening of the device, and severe infection can all increase the likelihood of revision surgery to remove and replace the device. Revision surgeries are typically more dangerous than the original hip replacement procedure as they carry greater risk to the patient and are less likely to succeed than the first implantation—potentially causing permanent loss of range of motion and disability in some patients.

 

  • The Zimmer M/L Taper comprises three parts: the modular neck, the femoral stem, and the femoral head. Each piece comes in many sizes, which was marketed by the company as offering a more secure fit for both male and female patients. The device was also supposed to offer greater conservation of the bone tissue surrounding the implant and lower the risk of dislocation, as the custom-fit device would ideally move in the joint similar to the patient’s natural hip.
  • Shortly after receiving FDA approval for the metal hip device, Zimmer received complaints regarding patients who required revision surgery to remove and replace the Kinectiv Modular Neck System due to metallosis diagnoses and device failure. Reports of similar complications began flooding the FDA’s database. Despite knowing that the Kinectiv Modular Neck System was defective and had failed often, causing patients to undergo complicated, expensive, and painful revision surgeries with extensive recovery time, Zimmer continues to sell and promote the defective metal hip implant, while actively concealing its harmful defects from the public and medical community. Strode maintains that corporate greed motivated Zimmer to misrepresent the safety and efficacy of the Kinectiv hip system, protecting its bottom line at the peril of patients.
  • FDA Warning About the Durom Cup Hip
  • The FDA approved Zimmer Durom Acetabular Component (commonly known as Durom Cup) in 2006 for total hip replacement to address the durability and range of motion of the joint. Most of the Zimmer Holdings Inc. came to the market after going through the FDA’s 510(k) clearance process. The young patients with more physical lifestyle were targeted and implanted, and it was observed it led to serious injuries within a short time.
  • Serious Alleged Injuries Include:

 

  • Premature Loosening
  • Severe Pain
  • Inflammation and Swelling
  • Limited Mobility
  • Infection
  • Bone, Joint, Muscle or Neurological Damage
  • Shedding of Metal Debris into The Bloodstream
  • Metallosis (The Build-Up of Metal Ions In The Body)
  • Component Corrosion
  • Popping, Crunching or Other Noises from The Hip Caused By Movement

 

  • Fractures of One Or More ComponentsZimmer’s Kinectiv device came just a few years after its Durom Acetabular Component, also called the Durom Cup, caused issues for thousands of patients. The Durom Cup was constructed from a single sheet of alloy metal supposed to fuse with the bone and stay in place without bone cement. Unfortunately, some patients found that the device failed to bond with the bone, causing pain, nerve damage, dislocation, and the need for revision surgery as early as two years from the original implantation.
  • The Indiana-based medical device manufacturer already has its hands full with hip replacement lawsuits filed over its Durom Acetabular Component, or Durom Cup. Plaintiffs in Zimmer hip replacement lawsuits claim that the Durom Cup was defectively designed and is prone to deterioration and dislocation inside the body. The metal-on-metal design of the implant can cause toxic metal particles being released into the bloodstream. These metal ions can build up in the soft tissues of the body and lead to metallosis, which causes fatigue, dizziness, and extreme pain.
  • Although Zimmer Holdings Inc. voluntarily suspended sales of its Durom Cup device in 2008, it reintroduced the product shortly afterward despite growing reports of injury. Zimmer has paid nearly $400 million in settlements to patients who required revision surgery after receiving the Durom Cup, and many cases are still pending litigation in court. Cases have been filed against Zimmer at both the state and federal levels, and claims against the company include:

 

  • Failure to warn of known risks of a harmful device
  • Failure to properly test the Durom Cup before releasing it onto the U.S. market
  • Misleading marketing and promotion of a medical device
  • Releasing inaccurate information about the hip replacement’s safety and effectiveness
  • Unfairly profiting from sales of a device that had known consumer dangers

 

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