Attorney at Graves McLain Injury Lawyers

Practice Areas: Wrongful Death, Medical Malpractice, Bad Faith Insurance, Car Accidents, T-Bone Tractor-Trailer Accidents, Dangerous Drugs

When you agree to undergo shoulder replacement surgery, you trust the medical team and the devices used. But what happens when the very device that’s supposed to help you starts to fail? That’s precisely what led to the Zimmer Biomet Comprehensive Reverse Shoulder recall.

This blog explains what the device is, why it was recalled, how it may affect patients, and what legal options are available. If you or a loved one had shoulder surgery and experienced complications, this guide will help you understand what to do next.

What Is the Zimmer Biomet Comprehensive Reverse Shoulder Device?

The Zimmer Biomet Comprehensive Reverse Shoulder system is a surgical implant used in shoulder replacement procedures. It’s often recommended for patients with severe rotator cuff tears or shoulder joint damage due to arthritis or a failed previous surgery.

The device is designed to help restore shoulder motion by changing how the shoulder joint works. Instead of relying on the rotator cuff, it uses different muscle groups to move the joint. It’s commonly used when traditional shoulder replacements aren’t an option.

But despite its purpose, many patients who received this implant later experienced serious problems. The issue became so widespread that the U.S. Food and Drug Administration (FDA) issued its most serious type of recall.

The FDA classified the Zimmer Biomet Comprehensive Reverse Shoulder recall as Class I, indicating the risk of serious injury or death. – U.S. Food and Drug Administration.

Why Was This Shoulder Device Recalled?

Zimmer Biomet voluntarily recalled the Comprehensive Reverse Shoulder device after it was found to break more often than the label suggested. These fractures can lead to severe complications, including the need for another surgery.

The FDA labeled this as a Class I recall, which is the most urgent classification. It means that using the product could result in serious health problems or even death.

Device fractures have occurred at a rate higher than what was indicated on the original product labeling, leading to an increased risk of revision surgeries and potential loss of function. – Zimmer Biomet Recall Notice.

Some patients who received this implant suffered from pain, lost mobility, and had to undergo complex revision surgeries. Others faced permanent shoulder damage or infections due to the failure of the device.

Medical device recalls are not uncommon, but Class I recalls represent the most severe risk to patient safety and require immediate action.FDA Recall Classification Definitions.

Legal Implications for Patients Affected by the Recall

If you were harmed by a defective medical device like the Zimmer Biomet shoulder implant, you may have a legal case. Product liability lawsuits allow injured patients to seek compensation for their losses.

These lawsuits can claim that the product had a defective design, was poorly manufactured, or did not come with proper warnings. Patients do not need to prove that the company intended harm—only that the device was unreasonably dangerous.

If you needed revision surgery, lost mobility, missed work, or suffered pain due to implant failure, a lawsuit could help cover those costs.

Product liability lawsuits may help cover the cost of revision surgery, lost wages, pain and suffering, and long-term medical complications. – American Bar Association – Tort Law Overview

Other Zimmer Biomet Recalls and Similar Hip Device Failures

Zimmer and Biomet have a history of medical device recalls. In fact, both companies have recalled various hip replacement devices over the years due to similar problems. Some of these issues included metal-on-metal designs that caused tissue damage and early device failure.

The Comprehensive Reverse Shoulder recall fits into a broader pattern of concern over orthopedic devices. Patients and doctors alike have questioned the long-term safety of certain Zimmer Biomet products.

What to Do If You Have a Recalled Zimmer Shoulder Implant

If you’re unsure whether your shoulder implant is part of the recall, start by contacting your orthopedic surgeon. They can check your medical records and tell you the make and model of the device used.

Common symptoms of implant failure include:

  • Constant pain in the shoulder
  • Grinding or clicking sounds
  • Swelling or infection around the joint
  • Loss of motion or strength
  • The need for additional surgery

If you’re experiencing any of these symptoms, get medical help right away. Then, speak with a lawyer who handles defective medical device claims.

Preserving evidence is critical. Keep all medical records, X-rays, and discharge summaries. If you’ve already had revision surgery, request operative notes and pathology reports.

Reported Complications from Zimmer Biomet Shoulder Implant Failures

Complication

Description

Potential Outcome

Implant FractureDevice cracks or breaks post-implantationRevision surgery
Limited Range of MotionShoulder cannot move as intendedPhysical therapy, surgery
InfectionInternal infection around the implantAntibiotics or removal
Nerve DamageTingling, numbness, or loss of strengthMay become permanent
Device Loosening or DisplacementImplant moves from its original positionPain, instability, surgery

How Graves McLain Injury Lawyers Can Help

At Graves McLain Injury Lawyers, we understand how devastating it can be to deal with a failed medical implant. Our team has handled many product liability claims, including those involving defective orthopedic devices.

We work with medical experts to investigate what went wrong and help clients hold manufacturers accountable. If you live in Tulsa or anywhere in Oklahoma and were affected by the Zimmer Biomet shoulder implant, we’re here to help guide you through your options.

Frequently Asked Questions

How do I know if my Zimmer shoulder implant was recalled?

You can request your surgical records from the hospital or your orthopedic surgeon. If the implant model matches the recalled Comprehensive Reverse Shoulder system, consult a product liability lawyer for the next steps.

What is a Class I recall?

A Class I recall is the most serious recall issued by the FDA. It means the product may cause serious health problems or death if used.

What symptoms might suggest my shoulder implant has failed?

Common symptoms include ongoing pain, reduced mobility, grinding or clicking sounds, instability in the shoulder, and infection indicators include fluid retention and fever.

Can I still sue if the implant failed years after surgery?

In Oklahoma, product liability lawsuits must typically be filed within two years of discovering the injury. It’s essential to act quickly once you notice signs of implant failure.

Are Zimmer Biomet hip implants also under recall?

Yes. Zimmer and Biomet have issued multiple recalls for hip replacement products in the past, including metal-on-metal implants, due to safety issues similar to those seen with the shoulder device.

What can compensation cover in a defective medical device lawsuit?

Compensation may include revision surgery costs, lost wages, Medical expenses, pain, and long-term impairment.

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Conclusion

The Zimmer Biomet Comprehensive Reverse Shoulder recall has affected patients across the country. For many, it means unexpected pain, surgeries, and a long road to recovery. If you’ve experienced complications from this device, you may have legal options.

Taking action can help you recover the financial support you need—and help prevent future harm to others. Graves McLain Injury Lawyers is here to listen, investigate your case, and help you understand your next steps.

Please make an appointment for a free consultation with Graves McLain Injury Lawyers right now to find out how they can support your future.

When injury victims need a law firm with a reputation for excellence, turn to Graves McLain Injury Lawyers. We are a top-rated personal injury firm determined to be the best. With decades of award-winning representation, our clients recover the compensation they need to put their lives back together.

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