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In 2008, Biomet, Inc. launched their medical Comprehensive Reverse Shoulder System Humeral Tray device as a shoulder replacement implant to restore a patient’s arm movement. The clearance of the device by the Food and Drug Administration (FDA) bypassed the need for human clinical trials. Instead, the device was made available in the medical marketplace under the 510(K) fast-track program after Biomet showed that their new device was “substantially equivalent” to other shoulder replacement devices that had been previously approved by the FDA previously.
The comprehensive reverse shoulder system by Zimmer Biomet (in 2015, Zimmer Holdings acquired Biomet) provided significant benefits to patients who are suffering from rotator cuff tears who have developed severe shoulder arthritis arthroplasty conditions. In addition, surgeons use the new reverse shoulder system for patients who require a joint replacement from a previously failed implant device. When properly surgically implanted, the shoulder replacement device assists patients by restoring their arm movement.
What Is a Shoulder Replacement Device?
Shoulder replacement surgical procedures are often performed on damaged joints that require a prosthesis device replacement. In some procedures, both the ball and socket are replaced while other procedures involve only the replacement of the ball of the humerus bone. In total shoulder replacement procedures, the surgeon will implant a short stem humeral device. However, the patient must have healthy bone material at the implant site.
The surgeon will attach the implanted device using cement free anchorage to ensure that the metal or ceramic device is secured in place appropriately. However, many devices fail over time when the implant becomes loose or fractures. Typically, when a device failure occurs, the only available option is to undergo revision surgery and have the damaged unsuccessful implant removed and replaced with a better replacement unit.
The device manufactured and sold by Zimmer Biomet involves a reverse total shoulder replacement implant that apparently provides optimal outcomes over conventional shoulder implants. This is especially important for individuals who suffer from cuff tear arthropathy because it helps normalize the arm’s range of motion. Precisely, this type of implant uses the deltoid muscle for stability and operation of the arm in its range of motion compared to the rotator cuff. This type of operation is not for every patient suffering from cuff tear arthropathy.
This shoulder replacement surgical procedure ranks third in joint reconstructions in the U.S. and typical patients include the elderly and obese. Unfortunately, this specific implant device was recalled by the Food and Drug Administration in a Class I (the most serious) recall in February 2017.
FDA Shoulder Replacement Recall
The U.S. Food and Drug Administration (FDA) announced a Class I recall involving the Zimmer Biomet comprehensive reverse shoulder implant due to failures of its design, stating that the implant is dangerous. The recall was initiated due to the numerous complaints reported by patients who had experienced shoulder fractures that led to serious injuries including infections, permanent loss of shoulder use and severe pain. The FDA determined that the fractured implants had the potential risk of causing the patient severe injuries or death.
This announcement by the FDA came just two months after Zimmer Biomet notified hospitals and doctors of the problem through an Urgent Medical Device Recall Notice sent out in December 2016. The voluntary recall initiated by Zimmer Biomet on December 20, 2016, encompasses a specific Biomet Comprehensive Reverse Shoulder Humeral lot #115340 with a manufacturing date from August 25, 2008, through September 27, 2011. The company claims that these units were distributed to the medical marketplace from October 2008 through September 2015.
While this specific recall has caused significant harm to the patients who undergo a Zimmer Biomet total shoulder replacement, this is not the first time that Biomet has faced a federal agency recall. In fact, their Comprehensive Reverse Shoulder devices have twice been recalled by the FDA, including in:
- September, 2010 – The company’s comprehensive reverse shoulder humeral tray with a locking ring was recalled by the federal agency due to numerous complaints that the implant was fracturing. It was later determined that many of these devices had joint fractures between the base plate and the trunnion.
- April, 2011 – The company’s Custom Comprehensive Reverse Shoulder Humeral Trays were recalled due to a locking ring issue due to incorrect assembling.
High Fracture Rate
Due to the design defect of the Zimmer Biomet comprehensive reverse shoulder implant, many patients have experienced high fracture rates that lead to serious complications that include:
- Loss of healthy bone
- Implant weakness and instability causing a loosening of the implant
- Device failure
- “Frozen” shoulder
- Device mispositioning and fracturing
- Loss of shoulder function
- Nerve damage
- Device failure
- Permanent disability
- Shortening of the arm post-surgery
- Fluid or blood build up in the joint
- Wrongful death
Many patients who experienced a fracturing of their newly implanted device were forced to undergo revision surgery to replace the broken unit with a stronger device. However, these revision surgeries had the potential risk of causing serious side effects including infections, loss of shoulder feeling and function, and wrongful death.
Even though this specific unit has a high fracture rate and has undergone an FDA Class I recall that called for pulling the device from use, the notice sent by the federal agency instructs surgeons to continue monitoring devices surgically implanted in their patients. However, the FDA and the device manufacturer have not yet provided pertinent instructions on how monitoring should be performed.
Zimmer Biomet Lawsuit Settlement
In February 2016, Zimmer Biomet settled a shoulder replacement lawsuit by agreeing to pay $350,000 to an injured plaintiff. The plaintiff in the case was a Colorado man who had suffered two Comprehensive Reverse Shoulder implant fractures. The case (#14-02667) was filed in the U.S. District Court for the District of Colorado. The patient had undergone revision surgery of both shoulder replacements back in 2012 and 2013.
After each device was replaced, a comprehensive visual inspection was conducted to reveal that each device shows signs of major fracturing at the joint where the base plate and trunnion come together.
Consult a Doctor Regarding Your
Patients who have undergone a total shoulder replacement surgical procedure and experienced severe pain or other side effects in their shoulder should consider consulting their doctor as quickly as possible. This is because any fracture can cause extensive damage to the joint and surrounding tissue, which could exacerbate a minor injury and lead to infection and, potentially, death.
A medical professional can provide advice and diagnosis relating to the health of the shoulder replacement device and recommend options on how to correct the problem or treat an infection.
Filing a Lawsuit to Recover Compensation for Your Pain, Disability & Medical Expenses
Zimmer Biomet is one of the leading global medical device manufacturers. The company sells over 1 million joint replacement units for the elbow, foot, ankle, hip, shoulder, and knee, accounting for more than $4.5 billion in sales every year. However, since February 2017, Zimmer Biomet started facing financial liability for their design, manufacturing, and selling of an extremely dangerous medical device. Many attorneys are now filing lawsuits against the health care device manufacturer over their failure to warn patients adequately about the potential risks associated with their comprehensive reverse shoulder system implant device.
These suits are based on failed medical shoulder replacement devices that were distributed and surgically implanted between October 2008 and September 2015. Any individual who suffers injury, damages or losses associated with the defective device manufactured, distributed or implanted from October 2008 through December 2016 is likely eligible to file a lawsuit or compensation claim to obtain financial recovery.
While there is no predictive value on the successful outcome of a Comprehensive Reverse Shoulder System lawsuit, in 2016, the company paid out $350,000 to settle the first lawsuit filed against the company over the defective unit.
That said, these cases are complex and negotiating a settlement or presenting evidence in front of a judge and jury can be complicated. Because of that, many potential plaintiffs will file a lawsuit and build their case on the severe complications associated with the defective medical device or their need for revision surgery to replace the defective unit and undergo painful months of rehabilitation.
Hiring an Attorney to Prosecute a Shoulder Replacement Defect
The reputable shoulder replacement recall lawyers at the Drug Law Center represent injured persons in complex medical cases. Our team of dedicated attorneys fights aggressively on your behalf to ensure you recover full financial compensation for your injuries and losses. We have years of experience in battling medical health care giants including Zimmer Biomet that makes millions of dollars in profits every year selling medical devices.
Contact us today to schedule an initial free consultation. Speak with our Zimmer shoulder replacement injury attorneys to discuss the merits of your case. We can provide you numerous options on how to proceed including working on your behalf in filing your claim to successfully resolve your financial compensation case. We provide a “No-Win/No-Pay” Guarantee, meaning we get paid for our legal services only after we have successfully negotiated an acceptable out of court settlement on your behalf or have won a jury monetary award at trial.