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DePuy Synthes Elbow Lawsuit Attorney

DePuy Synthes Elbow Replacement Prosthetic Device linked to dozens of reports of serious complications including loosening, osteolysis, poor joint mechanics, bone tissue fractures, soft tissue damage, revision surgery. Manufacturer pulled the Radial Head Prosthesis System off the U.S. market in 2016 after it was linked to more than 40 reports of loosening.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt

Lawsuits allege that DePuy Synthes (a Johnson & Johnson company) manufactured a defective elbow replacement implant and that it failed to warn the public and medical communities about the risk of loosening, medical device failure, and other potential complications.

Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by elbow replacement complications, you should contact our law firm immediately for a free case review. You may be entitled to compensation by filing a suit and our lawyers can help.

What is the Radial Head Prosthesis System?

The Radial Head Prosthesis System (revision joint replacement system) features 2 pieces that are used as a primary or revision joint of the radial head of the elbow. The ascension modular head is made of a cobalt chrome head and titanium alloy stem components and stem bone interface. This is combined with its integral side-loading and screw application for in-situ assembly.

There are 24 heads and 10 stems that go along with the Depuy Synthes Elbow Implant. It allows surgeons a choice of 240 combinations to choose from for the elbow implant. The side-loading component allows surgeons to make smaller incisions on the patient.

The Radial Head Prosthesis System may be used for:

  • Restoring joint function properly
  • Replacing the radial head for post-traumatic or degenerative disabilities
  • Primary replacement after the radial head has been fractured
  • Symptomatic episodes after resection of the radial head
  • Revision after unsuccessful arthroplasty of the radial head

Fundamental Technological Characteristics

DePuy Elbow Implant Recall

According to the National Center for Biotechnology Information, in January 2017, Johnson & Johnson announced that it was recalling its DePuy Synthes radial head prosthesis amid more than 40 reports of loosening in the component that anchors the implant in the arm’s radius bone. [1]

The entire device is used for primary and revision replacement of the radial head, but only the radial stem that is implanted into the radius has been associated with the loosening problem, according to a letter J&J sent to physicians on Dec. 30, 2016.

Based on the currently available data, we believe the cause to be multifactorial (including possible product characteristics, operative and patient factors), but we have not been able to fully characterize these factors – the company said

Consequently, we have not been able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and have decided to remove the DePuy Synthes Radial Head Prosthesis Stem from the global market

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DePuy Trial Head Recalls

As claimed by the FDA, DePuy in Feb. 2013 recalled 147 of the DePuy Synthes Radial Head Prosthesis Systems due to a problem with their trial head. A trial head is employed during surgery to ascertain if the actual head that will be implanted will function as intended after the procedure. [2]

The company is said to have reported a worrisome finding. They claimed that the trial head that was shipped with the elbow replacement implants could come loose from the stem during surgery. It also said that the problem did not cause any adverse events at the time of the earlier recall.

Faulty DePuy Elbow Implant Lawsuit

Why Did the FDA Approve the DePuy Implant?

The DePuy Synthes Radial Head Prosthesis System was approved in June 2011 through the U.S. Food and Drug Administration 510(k) process, which allows a company to market certain devices if they can simply show that the product is “substantially equivalent” in safety and effectiveness to other devices already on the market. They do not have to put the device through more rigorous safety tests.

DePuy and Synthes merged around the time of the approval, but Synthes had developed the implant and shepherded it through the FDA approval process.

Synthes had presented the device as substantially similar to 2 other elbow implants already on the market.

The surface of the device, critical for attaching to the bone and potentially important in the device loosening, was compared in Synthes’ application to 10 other existing spinal fusion devices. These included two versions of dental implants.

Synthes Radial Head Prosthesis

DePuy Radial Head Prosthesis System Complications and Statistics

  • Severe pain
  • Osteolysis (bone loss)
  • Bone fractures
  • Soft tissue damage/irritation
  • Symptomatic loosening implant
  • Premature failure
  • Surgery pain osteolysis
  • Corrective surgery
  • The need for revision surgery

The study assessed 77 surgical meshes cleared by the FDA between 2013 and 2015, finding that they were based on 771 interconnected predicate claims from 400 other devices.

These devices were predominantly descended from six meshes present on the market before 1976.

Of concern, 16% of the recently cleared devices were connected through equivalence claims to three predicate meshes that had been recalled due to design and material-related flaws.

Implant Loosening and Revision Surgery

DePuy elbow lawsuits involved those complications that led DePuy to recall the implants. Patients complained about implant loosening, dislocation, and revision surgery.

The first sign that an elbow replacement device has loosened may be pain in the forearm. Determining the device has loosened can require multiple tests. Repairing a defective DePuy Synthes Radial Head Prosthesis Device could require additional surgery to remove and replace the faulty stem.

According to the National Institute of Health, between 2014 and the time of the recall in December 2016, the FDA had received more than 40 reports of this device loosening. [3]

The National Institutes of Health (NIH) warns that the long-term prognosis for multiple surgeries is often not as successful as the original replacement. Loosening may have led to other complications including bone fracture and bone loss. Each of these complications may mean more medical bills for patients harmed by a faulty stem.

Defective Medical Devices

Symptoms of Loosening of the DePuy Synthes Radial Head Prosthesis System

Not all stems of the DePuy Synthes Radial Head Prosthesis System loosen, and determining if any individual implant will fail can be difficult. However, the first sign of a problem may be pain in the forearm.

According to the National Library of Medicine, a 2012 study published in the Journal of Shoulder and Elbow Surgery found that aches and pain that occur after a radial head replacement may often be misinterpreted, and that there is a lack of reliable guidelines for diagnosing loosening of the radial head prosthesis. [4]

The researchers also found that forearm pain was a major indicator of loosening of implants that are similar to the design of the faulty elbow implant.

When a patient with a radial head prosthesis suffers from proximal radial forearm pain, it is an indication of symptomatic mechanical loosening, according to the study.

If the prosthetic unit has a textured surface to support the ingrowths of the bone and was implanted without the use of cement, it is considered a strong indicator for loosening, even when there are no radiographic signs.

Signs that indicate loosening of an elbow replacement implant include pain, swelling, and impaired range of joint motion. If a patient who has had surgery for elbow replacement experiences these problems, the physician will rely on certain tests to determine if the actual cause is the loosening of the implant. They may order examinations which may include:

  • Bone scans
  • X-rays
  • Other diagnostic imaging or clinical work-ups

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Have you or a loved one suffered severe pain or injury from a defective medical device?

Have There Been Any Settlements?

Lawsuits filed over complications alleged from DePuy Synthes elbow replacements are still in the early stages, and no major settlements have been reached to our knowledge.

However, the mere fact that DePuy pulled the Radial Head Prosthesis System off the market after it was linked to dozens of reports of loosening indicates the company is aware of the dangers associated with the device, and that it may be willing to settle cases rather than fight them out in court.

Elbow Joint Replacing

Can I File a DePuy Synthes Elbow Revision Surgery Lawsuit?

Only a qualified attorney can determine whether you are eligible to file a lawsuit against DePuy Synthes, maker of the radial head prosthesis, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.

Most cases involving certain medical devices allege that a product was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain potential complication.

In the case of the DePuy Synthes Elbow, our attorneys suspect that patients may be able to take legal action in light of claims that J&J failed to adequately warn medical professionals and patients about the risk of implant loosening and other side effects.

How Can Filing a Lawsuit Help Me?

By filing a lawsuit against the maker of the DePuy Elbow, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your injury, as well as for damages for pain and suffering.

Additionally, filing a lawsuit can help hold the drug’s manufacturer accountable for releasing an allegedly defective product into the marketplace, and to discourage other medical device manufacturers from engaging in similar conduct.

Related: All the Medical Devices Lawsuits that We’ve Covered

Radial Head Prosthesis System

Get a Free DePuy Synthes Elbow Lawsuit Evaluation With Our Lawyers

The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in DePuy Synthes Elbow Lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.

Free Case Evaluation: Again, if you or a loved one was injured, you should contact Schmidt & Clark’s lawyers immediately for legal services. You may be entitled to a settlement by filing a suit and we can help.



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